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PubMedDate not supplied

[Variability of home dietary habits of families living in Bamako (Mali) according to their socioeconomic status].

We investigated the influence of standard of living on the dietary and eating habits of families in Bamako (Mali). Family meals eaten at home at any time of day were studied. Families were selected for the study according to two criteria: the place of residence and the domestic commodities and urban investments. Thus, 24 families were included from affluent and 24 from moderately affluent neighborhoods, and 26 families from poor neighborhoods. All families ate three meals a day, each including staples and sauce. However, the dishes selected for the different meals and their ingredients varied considerably with the family's status. Cereals were the main component of breakfast, but the type varied from one category of family to another. All poor families and 79% of the intermediate group and only 54% of the affluent group ate millet/sorghum. Seventy-five % of the affluent, 13% of the intermediate and none of the poor families drank coffee at breakfast. Fifty % of the affluent, 29% of the intermediate and 19% of the poor families ate rice with nadji sauce at lunch. The quality of the nadji sauce varied with economic status. Tigadeguena sauce was eaten with rice in 17% of the affluent families, 50% of the intermediate group and 12% of the poor families. Very little millet/sorghum was eaten by the affluent at lunch, whereas it was included in lunch by over half the poor and one fifth of the intermediate families. The diversity of dishes was larger at supper, but only in the affluent families which had 2 to 4 different dishes or produce. They included garden vegetable salads and stews, with or without bread. Dinner for the intermediate and poor families was similar to lunch, that is a cereal base and a sauce. Home eating habits also differed according to status. In the affluent families breakfast was eaten alone, whereas in the poor families it was a communal meal. The intermediate group displayed both patterns. Affluent families tried to alternate and diversify their food intake from one meal to another, whereas the diet of the poor was monotonous. Most intermediate families tried to alternate a small range of staples (rice and traditional cereals) although this necessitated reducing the quality of the sauce. Our study shows that eating habits are affected by both cultural factors and standard of living.

Adolescent↗

PubMed1996

Effect of gallbladder contraction induced cholagogia on the pharmacokinetic profile of a sustained-release theophylline formulation.

Bile excretion might change the physiological milieu of the duodenum resulting in enhanced absorption of a drug due to increased solubilisation. This possible influence of bile salts following stimulation of gallbladder emptying via the release of cholecystokinin on the pharmacokinetics of a sustained-release theophylline (CAS 58-55-9) preparation (Bronchoretard) was evaluated in this study. An open, randomised 3-way cross-over study in 12 healthy, non-smoking volunteers was selected to prove or reject this hypothesis. All subjects received 500 mg of the sustained-release theophylline formulation under two different cholagogia stimulating test conditions and under a fasting reference condition. A standard breakfast and i.m. application of cholecystokinin enabled modulation of bile flow; a moderate and extreme contraction of the gallbladder could be induced after a standard breakfast and after i.m. application of cholecystokinin, respectively. Following a standard breakfast, gallbladder volumes were approximately halved (50.6%) compared to the baseline volume after 79 min. Injection of 0.3 micrograms/kg body weight cholecystokinin resulted in quick and complete gallbladder evacuation (94.6%) 36 min after the application of this cholagogue stimulus. Gallbladder volumes remained approximately constant under fasting conditions. This manipulation of bile flow did not influence concentration/time profiles of the sustained-release theophylline preparation compared to the fasting condition. Even almost complete evacuation of the gallbladder after application of cholecystokinin did not modify concentration/time profiles of theophylline in a relevant way. An unintentional rapid release of theophylline could be excluded for this sustained-release formulation for all three treatments, as not a single case of dose-dumping was observed. Furthermore, in vitro dissolution investigations using surfactants are neither predictive of food effects nor bile influence on in vivo absorption at least for the sustained-release formulation tested.

Adult↗

PubMed1996

[Some life style elements in students from public and non-public secondary schools].

The studies were performed on 825 school-children 16-17 years old (512 girls and 313 boys) from first and second classes of secondary schools in some district towns in our country. 406 school-children attended public and 419 non-public schools. In the study was used a questionnaire worked out in the Institute for Children and Youth in Berlin. The analysis of the data collected by our co-workers of the District Sanitary-Epidemiological Stations enable the following conclusions: In both groups of pupils from the public and non-public secondary schools similar abnormalities in their everyday life detrimental for health were found. Improper dietary habits, sleep deficits, short time for physical activity belonged to the most important and most frequent lifestyle abnormalities. 18% of the respondents went to school without eating breakfast at home, 19% took their breakfast not every day and 3% of the examined pupils don't eat breakfast at all. During the working-days 14% of pupils were eating no warm meal. This was the cause more frequent in pupils from non-public schools (19%) than from public schools (4%). 18% of the respondents were eating not always dinner on working days. 82% of pupils were going to bed too late: 49% after 10 o'clock p.m. and 34% after 11 o'clock p.m. Greater irregularities were found among boys (92%) than among girls (76%). 13% of pupils from the public and non-public schools spent only 30 minutes, the way to school included, in the fresh air and 54% pupils in the public schools and 43% in non-public schools--about 1 hour.

Adolescent↗

PubMed1996

[Food habits in the school population from rural areas].

OBJECTIVE: To find the nutritional habits, qualitatively speaking, of school-children in our area in order to analyse their possible nutritional deficiencies and establish corrective measures. DESIGN: A crossover study with a randomised sample, stratified by school years. SETTING: A school in a rural area. PATIENTS AND OTHER PARTICIPANTS: A sample of students from this school: 101 out of 247 (41%). MEASUREMENTS AND RESULTS: Using a closed survey without prior notice to the pupils, the food taken the day before at different meals was recorded and placed in each of the 7 groups of the nutritional circle. In addition two food groups considered of high energy content and low nutritional value were included (group 8, cakes and group 9, sweets). 17.82% of pupils had correct nutrition. 99% had milk for breakfast. 37.62% had only milk for breakfast. 46% did not consume vegetables all day. 34% did not consume fruit all day. 34% did not consume pulses all day. 72.28% consumed cakes and/or sweets at some time during the day. CONCLUSIONS: It can be concluded that these school-children eat low-quality food and that this is independent of school cycles or gender. The food of 82% of school-children is incorrect, with insufficient vegetables, fruit and/or pulses. They eat little for breakfast. We propose introducing, jointly with the teachers, measures to correct the problems found.

Child↗

PubMedDate not supplied

[Insulin combinations: improving the treatment of juvenile diabetes].

In order to establish some general insulin therapy norms, a study was performed on a group of 77 young diabetics (average age 11.7) over the course of a 14 day stay at a summer camp. The children were placed on an appropriate diabetic diet and received twice daily insulin injections. 83.1% of the group (N = 64) ended up using a mixture of Regular and NPH insulin while the other 16.9% used only NPH insulin. Daily, two-thirds of the total dosage was given before breakfast (63.4 +/- 9.6%) and the other one-third (36.6 +/- 9.6%) was given before dinner. The proportion of mixed insulins were the following: before breakfast 10.3 +/- 6.6% Regular, 89.7 +/- 6.6% NPH; before dinner 12.5 +/- 7.3% Regular, 87.5 +/- 7.3% NPH, 14.9% of the blood glucose tests showed hypoglycemia. The majority of these results were after some physical activity (37.8% before breakfast, 20.7% before dinner) and a few (18.3%) become so at night. Thus, this work reflects the importance of proportion and regularity of insulin use, as well as the need for bedtime blood glucose levels in children with diabetes.

Blood Glucose↗

PubMed1998

[The effect of bile secretion on the pharmacokinetics of a theophylline sustained-release preparation].

Bile excretion changes the physiological milieu of the duodenum, possibly resulting in enhanced absorption of a drug due to increased solubilisation. This possible influence of bile salts following stimulation of gallbladder emptying by the release of cholecystokinin on the pharmacokinetics of a sustained release theophylline (CAS 58-55-9) preparation (Bronchoretard) was evaluated in this study. An open, randomised, 3-way crossover study in 12 healthy, non-smoking volunteers was selected to prove or reject this hypothesis. All subjects received 500 mg of the sustained release theophylline formulation under two different cholagogia stimulating test conditions compared with a fasting reference condition. A standard breakfast and i.m. administration of cholecystokinin enabled a reproducible modulation of bile flow: a moderate and extreme contraction of the gallbladder could be induced after a standard breakfast and after i.m. administration of cholecystokinin, respectively. Following a standard breakfast, gallbladder volumes were approximately halved (50.6%) compared to the baseline volume after 79 min. Injection of 0.3 microgram/kg body weight cholecystokinin resulted in fast and complete gallbladder evacuation (94.6%) 36 min after the application of this cholagogue stimulus. Gallbladder volumes remained more or less constant under fasting conditions. This manipulation of bile flow did not influence concentration/time profiles of the sustained release theophylline preparation compared to the fasting condition. Even almost complete evacuation of the gallbladder after administration of cholecystokinin did not modify the concentration/time profile of theophylline in a relevant way. An unintentional rapid release of theophylline could be excluded for this sustained release formulation for all three treatments, as not a single case of dose dumping was observed. Furthermore, in vitro dissolution investigations using synthetic surfactants can predict neither food effects nor bile influence on the in vivo absorption at least for the sustained release formulation tested.

Adult↗

PubMedDate not supplied

Weight reduction. Renal mineral and hormonal excretion during semistarvation in obese patients.

Three patients with exogenous obesity were studied while fed a 400-kcal constant metabolic diet, provided as a single daily meal served at consecutive ten-day periods, starting with either the "breakfast" protocol at 8 AM or the "dinner" protocol at 5 PM. Both patients 1 and 2 had notably greater weight loss with the breakfast protocol than with the dinner. However, in patient 3 this difference was not demonstrated. Urine samples, collected at four-hour intervals throughout the studies and analyzed for sodium, potassium, calcium, phosphorus, 17-hydroxycorticosteroids, and aldosterone secretions, showed differences in excretion of minerals and hormones with the timing of meals. The data tentatively show an achievement of greater weight loss when the isocaloric diet is given at 8 AM.

17-Hydroxycorticosteroids↗

PubMed1997

Von Willebrand factor and soluble E-selectin in hyperlipidaemia: relationship to lipids and vascular disease.

Our objective was to determine whether endothelial cell products von Willebrand factor and soluble E-selectin are related to serum lipids, lipoprotein (a), and vascular disease in patients with hyperlipidaemia. In order to achieve our aim, blood samples were obtained for four experiments from 1) 160 patients (49 with symptomatic vascular disease) with hypercholesterolaemia and an equal number of age and sex matched controls; 2) 31 patients who were studied serially before and after successful resolution of their hypercholesterolaemia; 3) 15 patients with hypertriglyceridaemia; and 4) 20 controls, half of whom consumed a lipid-rich breakfast. von Willebrand factor and soluble E-selectin were measured by enzyme linked immunosorbent assay (ELISA) using commercial reagents. In experiment (1) von Willebrand factor was increased in the patients with hypercholesterolaemia (P=0.0077) and was higher still in patients with vascular disease (P<0.0001). Soluble E-selectin was not influenced by hypercholesterolaemia or vascular disease. The correlation of von Willebrand factor with total and LDL cholesterol (both P<0.001) remained after both age and blood pressure were controlled. Experiment (2) showed that serial studies in patients over an average of 7 months a reduction in total cholesterol was associated with a reduction in von Willebrand factor (r=0.51, P=0.002). Experiment (3) demonstrated that von Willebrand factor was not increased in patients with hypertriglyceridaemia (median 8.9 mmol/L), and in experiment (4) a lipid-rich breakfast taken by fasted, healthy controls produced an increase in serum triglycerides (P<0.01) but did not influence von Willebrand factor over an 8 hour period. We conclude that von Willebrand factor, but not soluble E-selectin, is raised in hypercholesterolaemia and therefore may be a potential indicator of endothelial cell physiology in subjects with, or at risk of, atherosclerotic vascular disease.

Adult↗

PubMed1997

Monitoring of metabolic control in patients with non-insulin-dependent diabetes mellitus on oral hypoglycaemic agents: value of evening blood glucose determination.

Monitoring of metabolic control in patients with non-insulin-dependent (Type 2) diabetes (NIDDM) is usually based upon blood glucose assay in the morning (after an overnight fast) and in the postprandial state (breakfast or lunch). However, this schedule does not seek low blood glucose values, especially in the evening. We have conducted a prospective study of laboratory blood glucose profiles (8 am, 9.30 am after a 35 g carbohydrate breakfast and in the evening between 5 and 7 pm). We have included 58 consecutive NIDDM patients regularly followed in our clinic (39 men, age 60 +/- 11.5 years, diabetes duration 8.6 +/- 6.5 years, BMI 25.5 +/- 3 kg m-2), treated with the sulphonylurea gliclazide, alone (40-320 mg 24 h-1, mean 170 +/- 110 mg) (group 1, n = 32) or in combination with metformin (1000-3000 mg 24 h-1, 2400 +/- 620 mg) (group 2, n = 26). All patients were stable, with no change in dosage for at least 3 months. Mean glycaemic control was good (group 1 HbA1c: 6.5 +/- 1.1%, group 2: 6.9 +/- 0.7%). Evening blood glucose values were the lowest of the day in 26 patients of group 1 (81.3%) and in 22 of group 2 (84.6%). Mean evening blood glucose levels were lower (p = 0.001) than 8 am values (group 1: 5.8 +/- 1.4 vs 6.1 +/- 1.6 mmol l-1, group 2: 6.5 +/- 1.8 vs 6.9 +/- 1.9) and than 9.30 am values (group 1: 7.6 +/- 1.5, group 2: 12.3 +/- 2.8). No blood glucose values in the hypoglycaemic range were observed. HbA1c was strongly correlated (p = 0.002 to 0.0001) in the whole group with 8 am (r = 0.39), 9.30 am (r = 0.56), and evening blood glucose values (r = 0.42). These results indicate that, in patients treated with the sulphonylurea gliclazide, alone or in combination with metformin, the lowest blood glucose values occur in the evening more frequently (4/5) than in the morning. Therefore, evening blood glucose determination should be performed systematically in the course of the metabolic evaluation of NIDDM patients on oral hypoglycaemic agents.

Administration, Oral↗

PubMed1998

Effects of different glycaemic index foods and dietary fibre intake on glycaemic control in type 1 diabetic patients on intensive insulin therapy.

To evaluate the influence of a low glycaemic index (GI), high GI and high fibre diet on glycaemic control and insulin requirement in Type 1 diabetic patients on intensive insulin therapy, nine well-controlled, highly-motivated Type 1 diabetic patients were put on a control diet for 12 days and then randomized in a consecutive manner to 12 days of each diet, in a crossover design. During each experimental diet, the study subjects adjusted their premeal insulin (soluble) dose to maintain their 1-h postprandial capillary glucose at or below 10 mmol l(-1). At the end of each experimental diet, they were submitted to a standardized breakfast of the diet under study, using the same premeal insulin dose as that required for the control diet. The control diet contained 16.0+/-3.0 g of fibre day(-1) with a GI of 77.4+/-2.7 compared to 15.3+/-6.3 and 66.2+/-1.2 for the low GI diet, 17.1+/-7.2 and 92.9+/-3.6 for the high GI diet, and 56.1+/-3.6 (including 15 g of guar) and 73.5+/-2.1 for the high fibre diet. Prebreakfast capillary blood glucose (6.2+/-1.2 mmol l(-1)) on the low GI diet and postbreakfast capillary blood glucose (8.7+/-1.8 mmol l(-1)) on the high fibre diet were significantly lower than the values obtained with the control diet (8.0+/-1.8 and 10.6+/-2.4, respectively; p<0.05). No change in premeal or basal insulin dose was required. During the standardized breakfasts, the incremental area under the curve was 1.6+/-1.5 mmol l(-1) min(-1) for the control diet compared to 1.1+/-1.8 for the low GI diet, 3.2+/-1.4 for the high GI diet (p<0.05 versus low GI and high fibre; p=0.08 versus control), and 1.0+/-0.9 for the high fibre diet. These observations indicate that in well-controlled Type 1 diabetic subjects on intensive insulin therapy, major alterations in the GI and fibre content of meals induce small but significant changes in glucose profile. In everyday life, however, these differences are blunted, and plasma glucose remains within the target range for optimal metabolic control.

Blood Glucose↗

PubMed1996

Pharmacokinetics and food interaction of MK-462 in healthy males.

A study was conducted to assess the safety, tolerability, and pharmacokinetics of single intravenous (IV) doses of 5-90 micrograms kg-1 of MK-462, and the effect of food on the pharmacokinetics of MK-462 administered orally to healthy males. Results of this study indicate that IV doses of MK-462 from 5 to 90 micrograms kg-1 are well tolerated. The disposition kinetics of MK-462 were linear for IV doses up to and including 60 micrograms kg-1. The values of the plasma clearance (CL), steady-state volume of distribution (Vss), plasma terminal half-life (t1/2), and mean residence time in the body (MRT) of MK-462 averaged 1376 mL min-1, 140 L, 1.8 h, and 1.7 h, respectively, and remained essentially constant over the dosage range of 10-60 micrograms kg-1 of IV MK-462. However, as the dose increased from 60 to 90 micrograms kg-1, the mean value of the apparent CL decreased from 1376 to 807 mL min-1. Thus, elimination of MK-462 was dose dependent in this dosage range. Based on the disposition decomposition analysis (DDA), it was shown that the Vss value of MK-462 remained essentially constant over the dosage range of 10-90 micrograms kg-1 of IV MK-462. The following values of two dose-independent parameters were also calculated by using DDA: distribution clearance (CLd) = 2028 mL min-1, and mean transit time in the peripheral tissues (MTTT) = 0.74 h. The mean values of AUC, Cmax, tmax, and apparent t1/2 of MK-462 in 12 subjects each receiving a 40 mg tablet of MK-462 without breakfast were 330 ng.h mL-1, 77 ng mL-1, 1.6 h, and 1.8 h, respectively. Although administration of a standard breakfast prior to dosing increased the AUC value (by approximately 20%) of MK-462 and delayed its absorption, there were no significant effects of the meal on the values of Cmax and apparent t1/2 of MK-462.

Absorption↗

PubMed1996

The effect of food on the bioavailability of ibuprofen and flurbiprofen from sustained release formulations.

The effect of food on the plasma concentration-time profile of sustained release dosage forms of ibuprofen and flurbiprofen has been investigated in healthy Asian Indian volunteers, in two separate studies. In study 1, 20 volunteers were administered a single 200 mg multiple-unit sustained release capsule of flurbiprofen (Froben SR), after an overnight fast or a heavy vegetarian breakfast. Food produced a statistically significant increase in the mean (+/-SE) maximal plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC0-48). Cmax (+/-SE) increased from 9.88 +/- 0.48 mg L-1 (fasting) to 11.36 +/- 0.88 mg L-1 (postprandial) and AUC0-48 (+/-SE) increased from 120.78 +/- 9.64 mg h L-1 (fasting) to 149.73 +/- 12.24 mg h L-1 (postprandial). The mean (+/-SE) time to peak (tmax) was also significantly delayed from 3.85 +/- 0.27 h to 8.70 +/- 0.89 h. In study 2, 18 volunteers were administered a single 800 mg erodible sustained release matrix tablet of ibuprofen (Brufen Retard), after an overnight fast or along with a heavy vegetarian breakfast. The formulation exhibited multiple peaks (n > or = 2) on the plasma concentration-time curve. Although food did not affect the bioavailability of this formulation, there was a statistically significant increase in the mean (+/-SE) concentration of the first peak (Cpeak 1) from 14.21 +/- 1.38 mg L-1 (fasting) to 20.14 +/- 1.38 mg L-1 (with food). The time at which Cpeak 1 was reached was not influenced by the intake of food. Results indicate that while qualitative changes in the plasma concentration versus time curves are primarily influenced by the nature of the formulation and the type of meal, bioavailability is influenced by the absorption characteristics of the drug as well. Thus, despite a significant increase in peak plasma concentrations of both drugs with a meal, the bioavailability of flurbiprofen alone was enhanced.

Adult↗

PubMed1998

The effect of food on the bioavailability of dolasetron mesylate tablets.

Anzemet (dolasetron mesylate) is being developed for the prevention of chemotherapy-induced emesis and postoperative nausea and vomiting. Twenty-four healthy male subjects were orally dosed with dolasetron mesylate, 200 mg, after either an overnight fast or a high-fat breakfast. The ratio of the mean area under the plasma concentration-time curve of the reduced active metabolite (MDL 74,156) to infinity (AUC(0-infinity)) values in fed compared to fasting subjects was 86.3% with a 90% confidence interval for the ratio within (80, 125)%, indicating bioequivalence. The ratio of the mean MDL 74,156 maximum plasma concentration (Cmax) values was 70.6% in fed versus fasted subjects. The time to Cmax was statistically significantly longer after the high-fat breakfast (mean values, 1.11 h fasting and 1.80 h fed), probably due to delayed gastric emptying. It may be concluded that, although the rate of absorption was somewhat delayed, the extent of absorption did not change significantly when dolasetron mesylate was given with food.

Adult↗

PubMed1998

Assessment of effect of food, gender, and intra-subject variability in the pharmacokinetics of avitriptan.

The objectives of this study were to assess the effect of food and gender on the pharmacokinetics of avitripan. A group of 12 healthy men and 12 healthy women was administered a single 50 mg dose of avitriptan capsule under fasting conditions and 5 min after a high-fat breakfast. The two treatments were repeated in a replicate design to assess the intra-subject variability in the pharmacokinetics of avitriptan under fasted and fed conditions. There was a 1 week washout between treatments. Serial blood samples were collected over 24 h after dosing and analyzed by a validated HPLC method for avitriptan. The mean (SD) peak concentrations (Cmax) were 168 (86.4) ng mL-1 in the fasted condition and 57.3 (34.8) ng mL-1 in the fed condition in males and females combined. The corresponding areas under the plasma concentration curve (AUC) were 335 (162) and 185 (64.5) ng h mL-1, respectively. Both Cmax and AUC were significantly reduced in the fed condition. In addition, the time to peak concentration (tmax) was significantly delayed from a median of 45 min to 2 h after the high-fat breakfast. The clinical significance of this food effect is unclear at the present time. There were no gender differences nor a gender by food interaction in the pharmacokinetics of avitriptan. The intra- and inter-subject variability (%CV) in the Cmax and AUC of avitriptan in the fasted and fed conditions ranged from 10 to 60% in male and female subjects.

Adult↗

PubMedDate not supplied

The absorption of sustained-release methylphenidate formulations compared to an immediate-release formulation.

A crossover study in 18 subjects evaluated the plasma concentration-time profile of two different 20 mg sustained-release (SR) methylphenidate (MPH) tablets administered before breakfast, compared to a 10 mg immediate-release (IR) tablet administered before breakfast and again 5 h later, before lunch. Plasma MPH concentrations were determined using a sensitive and precise gas chromatography-mass spectrometry method, incorporating a deuterated internal standard. The mean peak MPH concentration was 6.4 ng ml-1 for the IR product versus 4.6 ng ml-1 and 4.8 ng ml-1 for the two SR formulations. Peak concentrations occurred at 3.3 h after dosing with the SR products, compared to 1.5 h after the first dose of the IR product. The extent of absorption for the three products, as determined from areas under the plasma concentration-time curves, were within 5 per cent of each other. There was no significant difference in rate or extent of absorption between the two SR formulations.

Biological Availability↗

PubMedDate not supplied

Effect of dietary fat content on the bioavailability of a sustained release quinidine gluconate tablet.

Quinidine gluconate 324 mg sustained release tablets (Quinaglute) was administered as a single dose to 15 healthy male subjects following an overnight fast, immediately following a high fat (HF) breakfast or immediately following a low fat (LF) breakfast. Serum samples were obtained over a 48 h period and analyzed for quinidine content using a high performance liquid chromatographic assay. Under the conditions of the study, both the rate and extent of quinidine bioavailability was significantly affected by food. The extent of bioavailability was statistically significantly greater (p less than 0.05) following both the HF and LF meals as compared to that in the fasted state. Rate of bioavailability was significantly enhanced following the LF meal as compared to that of the other two treatment groups. Although peak concentrations were greater and time to peak concentrations somewhat later following the HF meal versus those under fasting conditions, these differences were not statistically significant. In addition, the characteristics of the serum concentration-time profile (as defined by the number, magnitude, and time of occurrence of the multiple absorption maxima) was unique for each of the three treatment groups. Possible mechanisms underlying these results are explored.

Adolescent↗

PubMedDate not supplied

Absence of effect of food on alprazolam absorption from sustained release tablets.

This study examined the effect of food on alprazolam absorption from a mixed polymeric matrix sustained release (SR) tablet in 21 healthy adults. Each subject received each of three treatments according to a crossover design: 1 mg alprazolam SR tablet while fasting; 1 mg alprazolam SR tablet immediately after a standardized breakfast; 1 mg alprazolam conventional tablet while fasting. The breakfast contained approximately 33 g protein, 55 g fat, and 58 g carbohydrate (850 calories). Serial blood samples were obtained and plasma alprazolam levels determined by HPLC. Results indicate that the SR tablet was minimally affected by food. Relative bioavailabilities of the SR tablet while fasting and with food were 100 per cent and 97 per cent, respectively. Although statistically significant, differences in mean Cmax values between SR tablets administered with and without food were small (12 per cent increase with food). Rates of absorption as measured by mean tmax values were also nearly the same: 7.2 h while fasting and 7.0 h with food. Absorption was relatively uniform with the SR tablets. Coefficients of variation for Cmax, tmax, and AUC were somewhat smaller with the SR tablet than with the conventional tablet.

Alprazolam↗

PubMed1990

Pharmacokinetics of midaglizole, a new hypoglycaemic agent, in healthy subjects.

The objective of this study was to evaluate the pharmacokinetics of midaglizole, a new orally effective hypoglycaemic agent, in healthy male subjects. In Study I, volunteers were given single oral doses of 150, 200, 300, and 500 mg of midaglizole 20 min before breakfast. In Study II, 200 mg of midaglizole was given 30 min after breakfast. In Study III, multiple oral administration study was carried out at a dose of 200 mg t.i.d. 20 min before meals for 7 days. The disposition of midaglizole was adequately described by a one-compartment open model with first order absorption. It was essentially dose-dependent up to 500 mg given orally. The pharmacokinetic parameters calculated by employing this model indicated that the disposition of this drug was characterized by good absorption from the intestine, a wide distribution in the body, and a rapid excretion via the kidneys. The absorption rate of midaglizole from the intestine was definitely slowed by the presence of food, probably due to a decrease in the rate of gastric emptying. No clinical significant accumulation of midaglizole in the body was observed during or after multiple doses. A linear correlation was found between the area under the curve of plasma concentration of midaglizole versus time and the area calculated from the curve of change in blood glucose level versus time after oral administration of midaglizole.

Adult↗