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Biomedical subjects

Q Zaman

Publications and source records attributed to Q Zaman.

At least 19 recordsLinked to original sources
PubMed2005

Comparative pharmacokinetics of two tablet formulations of Losartan: bioequivalence assessment.

The pharmacokinetic profiles of two brands of losartan 50 mg tablets were compared in 24 healthy adult volunteers after a single oral dose in a randomized cross-over study. The study was conducted at the ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan. The reference (Cozaar, MSD, The Netherlands) and test (Blosart, Julphar, UAE) products were administered to fasting volunteers. Blood samples were collected at specified time intervals, and the plasma separated and analysed for losartan and its active metabolite (losartan carboxylic acid) using a validated HPLC method with fluorescence detection. Pharmacokinetic parameters AUC(0-t), AUC(0-alpha), C(max), T(max), T(1/2), elimination rate constant, MRT, Cl/F and Vss/F were determined from plasma concentration-time profiles of both formulations and found to be in good agreement with reported values. Three parameters (AUC(0-t), AUC(0-alpha), and C(max)) were compared statistically to evaluate the bioequivalence between the two brands, using statistical modules recommended by the FDA. Analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range (80%-125%) for bioequivalence. Based on these statistical inferences it was concluded that the two formulations exhibited comparable pharmacokinetic profiles and that Julphar's Blosart is bioequivalent to Cozaar of MSD, The Netherlands.

Adult↗
PubMed2005

Bioequivalence evaluation of two brands of lisinopril tablets (Lisotec and Zestril) in healthy human volunteers.

The bioequivalence of two brands of lisinopril 20 mg tablets was demonstrated in 28 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at ACDIMA Center for Bioequivalence and Pharmaceutical Studies, Amman, Jordan. Reference (Zestril, AstraZeneca, UK) and test (Lisotec, Julphar, UAE) products were administered to fasting volunteers on 2 treatment days separated by a 2-week washout period; blood samples were collected at specified time intervals, and the plasma was separated and analysed for lisinopril using a validated LC-MS/MS method at ACDIMA Laboratory. The pharmacokinetic parameters AUC(0-t), AUC(0- proportional), C(MAX), T(MAX), T(1/2) and the elimination rate constant were determined from the plasma concentration-time profiles for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Lisotec is bioequivalent to Zestril of AstraZeneca, UK.

Adolescent↗
PubMed2004

Bioequivalence evaluation of two brands of aceclofenac 100 mg tablets (Aceclofar and Bristaflam) in healthy human volunteers.

A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of aceclofenac 100 mg tablets, Aceclofar (Julphar, UAE) as test and Bristaflam (Bristol Myers Squibb, Egypt) as the reference product. The drug was administered with 240 ml of water after a 10 h overnight fast on two treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 24 h. Plasma harvested from blood was analysed for aceclofenac by a validated HPLC method with UV-visible detection capable of detecting aceclofenac in the range 0.2-8.0 microg/ml with the limit of quantitation as 0.2 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0- infinity ), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0- infinity), and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (100.0%-106.4% for AUC(0-t), 100.2%-106.8% for AUC(0- infinity ); 83.3%-102.8% for C(max)) of test/reference ratio for these parameters were found to be within the bioequivalence acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Aceclofar is bioequivalent to Bristaflam.

Administration, Oral↗
PubMed2003

Bioequivalence evaluation of two brands of furosemide 40 mg tablets (Salurin and Lasix) in healthy human volunteers.

A randomized, two-way, crossover, bioequivalence study was conducted in 24 fasting, healthy, male volunteers to compare two brands of furosemide 40 mg tablets, Salurin (Julphar, UAE) as test and Lasix (Hoechst AG, Germany) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in a joint venture with Al-Mowasah Hospital, Amman, Jordan. One tablet of either formulation was administered with 240 ml of water after a 10 h overnight fast. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested from blood was analysed for furosemide by a validated HPLC method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC(0-t), AUC(0-infinity), and C(max) to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the US FDA accepted bioequivalence range of 80%-125%. Based on these statistical inferences, Salurin was found to be bioequivalent to Lasix.

Administration, Oral↗
PubMed2003

How much of a priority is treating erectile dysfunction? A study of patients' perceptions.

BACKGROUND: Erectile dysfunction (ED) is one complication of diabetes for which the treatment is rationed. Despite considerable public debate there has been no formal assessment of the views of patients and sufferers of the priority of treating ED. AIMS: To determine the perceptions of diabetic patients of the relative priority of treating ED in comparison with treatments for other diabetic complications and common medical conditions. METHODS: Psychological measures were used to assess subjects' perceptions of the relative importance of ED in comparison with eight other common problems (blindness, foot ulcers, high blood pressure, impotence, kidney disease, high cholesterol, migraine, mild indigestion and sleeping difficulties). The concept of willingness to pay was used to assess the amount per month participants would be prepared to pay for treatment for ED and other conditions. Four groups (controls, healthy diabetic men, impotent diabetic men and impotent diabetic men not in a sexual relationship) were studied. RESULTS: Significant differences were found between the four groups with regard to the ranking of the importance of ED compared with other health problems. Impotent diabetic male patients were prepared to pay more for treatment for their condition than all other conditions except blindness and renal failure. CONCLUSIONS: Men with diabetes, in particular ED sufferers, believe ED has a major impact on quality of life and is as important to treat as many other conditions associated with diabetes.

Adaptation, Psychological↗
PubMed2002

Bioequivalence evaluation of two brands of gliclazide 80 mg tablets (Glyzide & Diamicron)--in healthy human volunteers.

A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of gliclazide 80 mg tablets, Glyzide (Julphar, UAE) as test and Diamicron (Servier Industries, France) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in joint venture with Speciality Hospital, Amman, Jordan. The drug was administered with 240 ml of 20% glucose solution after a 10 h overnight fasting. After dosing, serial blood samples were collected for a period of 48 h. Plasma harvested from blood was analyzed for gliclazide by validated HPLC method. Various pharmacokinetic parameters including AUC(0-t), AUC(0- proportional, variant), C(max), T(max), T(1/2), and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC(0-t), AUC(0- proportional, variant), and C(max) for bioequivalence evaluation of the two brands which revealed no significant difference between them, and 90% CI fell within US FDA accepted bioequivalence range of 80-125%. Based on these statistical inferences, Glyzide was judged bioequivalent to Diamicron.

Adolescent↗
PubMed2002

Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon & Glucophage)--in healthy human volunteers.

A randomized, two-way, crossover study was conducted in 24 fasting, healthy, male volunteers to compare the bioavailability of two brands of metformin 500 mg tablets; Dialon (Julphar, UAE) as test and Glucophage (Lipha Pharmaceutical Industries, France) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in joint venture with Al-Mowasah Hospital, Amman, Jordan. The drug was administered with 240 ml of water after a 10-h overnight fasting on two treatment days separated by 1-week washout period. After dosing, serial blood samples were collected for a period of 30 h. Plasma harvested from blood was analyzed for metformin by validated HPLC method with UV-visible detector capable to detect metformin in the range of 0.05-5.0 microg/ml with limit of quantitation of 0.05 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0-proportional to), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-proportional to) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (97.9-110.8% for AUC(0-t), 97.4-110.7% for AUC(0-proportional to); 95.3-110.5% for C(max)) of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Dialon is bioequivalent to Glucophage.

Adolescent↗
PubMed2002

Bioequivalence of two brands of ciprofloxacin 750 mg tablets (Sarf and Ciprobay) in healthy human volunteers.

An open, randomized, two-way crossover study was carried out in 28 healthy volunteers at Gulf Pharmaceutical Industries (Julphar), as a joint venture with Saqr Hospital, Ras Al-Khaimah, UAE. The two commercial brands used were Sarf (Julphar, UAE) as test and Ciprobay (Bayer AG, Germany) as reference product. The drug was administered to each subject with 240 mL of water after an overnight fasting in two treatment days separated by a one-week washout period. After dosing, serial blood samples were collected for a period of 24 hr and serum was separated and analyzed for ciprofloxacin using a sensitive, reproducible, and accurate high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection. Various pharmacokinetic parameters, including AUC0-t, AUC0-infinity, Cmax, Tmax, t1/2, and lambdaz, were determined from ciprofloxacin serum concentration-time profiles for both formulations and found to be in good agreement with reported values. The parameters AUC0-t, AUC0-infinity, and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on analysis of variance (ANOVA); the 90% confidence intervals (95.73-107.62%, 94.98-108.26%, 92.80-103.90% for AUC0-t, AUC0-infinity, Cmax, respectively) for the test/reference ratios of these parameters were within the bioequivalence acceptance range of 80-125%. Based on this data, it is concluded that both formulations are bioequivalent and are interchangeable in medical practice.

Adult↗
PubMed2001

Bioequivalence assessment of Azomycin (Julphar, UAE) as compared to Zithromax (Pfizer, USA)--two brands of azithromycin--in healthy human volunteers.

Two studies have been performed to assess the relative bioavailability of Azomycin (Julphar, UAE) as compared with Zithromax (Pfizer, USA) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved Azomycin capsules and the other Azomycin suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of azithromycin were administered as single dose on two treatment days separated by a 2 weeks washout period. After dosing, serial blood samples were collected for a period of 192 h. Plasma harvested from blood, was analysed for azithromycin by HPLC coupled with electrochemical detection. Various pharmacokinetic parameters including AUC(0-t,) AUC(0-infinity,) C(max), T(max), T(1/2) and K(elm) were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC(0-t), AUC(0-infinity) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratios of these parameters were found within the bioequivalence acceptance range of 80-125%. Based on these statistical inferences it was concluded that Azomycin capsule is bioequivalent to Zithromax capsule and Azomycin suspension is bioequivalent to Zithromax suspension.

Administration, Oral↗
PubMed1995

Effect of concurrent feeding of furazolidone and sodium chloride upon some clinical, pathological and cardiac morphometric parameters in broiler chicks.

Broiler chicks in different groups were fed furazolidone (0, 400 and 800 mg/kg feed) and sodium chloride (500 and 1510 mg/kg feed) separately and concurrently from 1 to 30 days of age. Furazolidone (Fz) induced ascites, leg weakness, convulsions, depression and mortality was exacerbated by concurrent feeding of 1510 mg NaCl. Hemorrhages in the liver, swollen kidneys, pallor of the kidneys and cystic testes were present in all birds fed furazolidone either alone or in combination with NaCl. However, at microscopic level, necrotic changes were observed in the liver and kidneys of birds fed NaCl only. Fz-induced cardiac ventricular dilatation and thinning of walls were more severe when 400 mg Fz was fed concurrently with 1510 mg NaCl but feeding of 800 mg Fz with the same level of NaCl resulted in partial amelioration of cardiac changes. It is suggested that high dietary NaCl may exacerbate and alter the clinical and morphological picture of Fz toxicosis.

Animals↗
PubMed1995

Experimental furazolidone toxicosis in broiler chicks: effect of dosage, duration and age upon clinical signs and some blood parameters.

Groups of broiler chicks of one day and three weeks of age were given feeds containing 0, 400, 800 and 1000 mg furazolidone (Fz)/kg for three weeks. The age of the birds and the dose and duration of Fz treatment significantly (P < or = 0.05) influenced the parameters studied. Clinical signs of Fz toxicosis included ascites, leg weakness and nervous derangement like convulsions and torticollis. The body weight also decreased. Ascites and nervous derangement was not observed in birds fed 400 mg Fz from one day of age. Fz-fed birds developed anaemia and had lower plasma total protein and albumin levels than those fed no Fz. The decrease in body weight was related to reduced feed intake. Decreases found in the haematological parameters and plasma proteins showed no correlation with the chicks' age but were related to the dose and duration of Fz treatment.

Anemia↗
PubMed1995

Furazolidone toxicosis in young broiler chicks: morphometric and pathological observations on heart and testes.

Broiler chicks 1 d and 3 w of age were given 0, 400, 800, or 1000 mg furazolidone (Fz)/kg feed for 4 w. Bi-ventricular heart dilatation (as measured by increases in ventricular diameter and thinning of the ventricular walls) was present in 1-d-old chicks fed 800 mg Fz, whereas in 3-w-old groups these changes occurred at 1000 mg Fz. There was no heart hypertrophy. Microscopic changes in the heart were not discernible in and Fz-fed birds. The liver had congestion and cytoplasmic vacuolation of hepatocytes. About 37-50% of the male birds in the different Fz-fed groups had testicular degeneration varying from mild to cystic enlargement. The degenerated testes had dilatation of seminiferous tubules; in cystic testes the seminiferous tubules were extremely dilated and had flattened epithelium. The interstitial tissue between the dilated tubules was compressed and atrophic.

Administration, Oral↗
PubMed1986

Left atrial myxoma in the elderly. Report of four patients over the age of 70 and review of the literature.

Myxoma of the atrium presents distinctive clinical profile, yet precise diagnosis of the tumor on the basis of clinical findings is often not made in the elderly patient as the symptoms are often attributed to "generalized arteriosclerosis of the elderly." The authors report the clinical findings in four elderly patients with left atrial myxoma in whom the diagnosis had not been clinically suspected before echocardiographic evaluation.

Aged↗
PubMed1979

Demonstration of dissimilar acute haemodynamic effects of ethanol and acetaldehyde.

To determine whether the acute cardiac depressant effects of ethanol could be attributed to its metabolite (acetaldehyde), either ethanol or acetaldehyde was intravenously infused into pentobarbital anaesthetised, closed-chest dogs. At a venous blood ethanol level of 199 +/- 43 (SE) mg . dl-1, ejection fraction had decreased from 35 +/- 2 to 30 +/-2%, P less than 0.05, max dP/dt/end-diastolic volume from 14.0 +/- 2.1 to 8.6 +/- 1.1 kPa . s-1 . cm-3 (105 +/- 16 to 65 +/- 8 mmHg . s-1 . cm-3), P less than 0.02, whereas end-diastolic volume (P less than 0.005), myocardial oxygen consumption (P less than 0.05) and coronary blood flow (P less than 0.005) had increased. Higher ethanol levels exaggerated these changes when peak arterial acetaldehyde was 20.2 +/- mumol . litre-1. By contrast, infusion of acetaldehyde to a peak blood level comparable with that produced by ethanol increased cardiac output from 2.4 +/- 0.2 to 2.8 +/- 0.2 litre-1 . min-1 P less than 0.01), coronary sinus oxygen saturation from 46 +/- 4 to 55 +/- 3% (P less than 0.25) and reduced systemic resistance from 8.0 +/- 0.7 to 6.3 +/- 0.5 kPa . litre-1 . min-1 (60 +/- 5 to 47 +/- 4 mmHg . litre-1 . min-1) (P less than 0.001). High dosage of acetaldehyde to a level of 129 +/- 23 mumol . litre-1 produced elevation of cardiac output (P less than 0.001), ejection fraction (P less than 0.01), coronary blood flow (P less than 0.02), whereas systemic resistance (P less than 0.001), heart rate (P less than 0.05) and myocardial oxygen consumption (P less than 0.05) decreased. Discontinuation of acetaldehyde infusion significantly reversed these changes. Max dP/dt/left ventricular end-diastolic volume and left ventricular end-diastolic volume were not significantly altered by acetaldehyde. Thus, ethanol depresses cardiac performance and increases myocardial oxygen consumption. By contrast, acetaldehyde at levels produced by ethanol metabolism improves cardiac performance, consequent to afterload reduction, and reduces myocardial oxygen consumption.

Acetaldehyde↗
PubMed1978

Assessment of atrioventricular conduction in aortic valve disease.

To determine the frequency of atrioventricular conduction disturbances in aortic valve disease, 26 consecutive patients (age 54 +/- 2 years) with symptomatic aortic valve disease were studied by His bundle electrocardiography at the time of cardiac catheterisation and were compared with a group of patients who underwent cardiac catheterisation and were found to have coronary artery or mitral valve disease but no aortic valve disease. Patients with aortic valve disease had significantly longer PR, AH, and HV intervals than cardiac patients not having this abnormality. Patients with aortic stenosis had prolonged HV, 52 +/- 6 vs +/- 42 +/- 2 ms (P = 0.06), whereas patients with chronic aortic regurgitation had prolonged PR, 245 +/- 27 vs 163 +/- 5 ms (P less than 0.001), and prolonged AH, 178 +/- 30 vs 102 +/- ms (P less than 0.001). Patients with combined lesions had significant prolongation of PR, AH, and HV intervals. Three patients with acute aortic regurgitation caused by endocarditis had normal atrioventricular conduction. Though the presence of valvular calcification did not significantly alter the pattern of atrioventricular conduction in these patients, those with calcified aortic valves had longer HV (P less than 0.005) than the control group. In addition, ventricular dysfunction or coronary artery disease did not affect the pattern of atrioventricular conduction in these patients. Thus, atrioventricular conduction disturbances are common in symptomatic aortic valve disease. With aortic stenosis the site of delay occurs more frequently below the His deflection, whereas in aortic regurgitation it is more frequent above the His deflection.

Adult↗
PubMed1977

Effect of autonomic blockade on the hemodynamic findings in acute cardiac tamponade.

Twenty-three closed-chest, alpha-chloralose-anesthetized, volume-expanded, alpha- and beta-adrenergic-blockaded dogs with rate fixed by atrial pacing had 30-90 ml of saline at 37 degrees C infused into the pericardial sac a) with vagus intact, b) after vagotomy, and c) with vagus intact but with systolic pressure augmented with a balloon. A significant reduction in left ventricular (LV) systolic pressure (SP), and cardiac output (CO) occurred at a pericardial volume of 30-60 ml, when LV end-diastolic (ED) and right atrial (RA) pressures were not increased. Whereas the percentage decline of CO, LVSP, maximum negative and maximum positive dP/dt was greater in group A (vagus intact) than in group B (vagus cut), significant residual depressed performance was demonstrated only in group B. In four paced, atropinized, beta-blockaded dogs, response to tamponade was similar to that in intact dogs; vagotomy at 90 ml in these dogs resulted in a fall in CO, a rise of LVSP and a significant elevation in LVED and RA pressures. Thus, in the early phases of cardiac tamponade a sympathetic neurohumoral response supports cardiac performance while the vagus nerve exerts a myocardial protective effect. Vagal afferents appear to modulate this response.

Adrenergic alpha-Antagonists↗
PubMed1977

Demonstration of a depressor reflex in acute cardiac tamponade.

Studies from our laboratory have demonstrated the presence of a vagally mediated reflex in acute cardiac tamponade. To determine the effect of thisreflex on cardiac performance, we continuously recorded hemodynamic parameters during induction of tamponade in 16 closed-chest mongrel dogs anesthetized with alpha chloralose. The studies were done 1 to 7 days following the insertion of a catheter in the pericardial sac. With increasing pericardial volume, there was a progressive deterioration of cardiac performance, the most marked changes occuring in the late phases of cardiac tamponade...

Animals↗