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J H Cavanaugh

Publications and source records attributed to J H Cavanaugh.

51 records · Page 3Linked to original sources
PubMedDate not supplied

Lansoprazole: an alternative method of administration of a capsule dosage formulation.

A single-dose, open-label, randomized, fasting, two-period, crossover bioavailability study was conducted in 24 healthy adult men to assess an alternative method of administration of lansoprazole capsules. Half of the subjects received regimen A (contents from a 30-mg capsule placed in a tablespoonful of applesauce), and the other half received regimen B (an intact 30-mg capsule) during period 1 of the crossover study. The regimens were reversed during the second period 1 week later. Blood samples were obtained over 12 hours and pharmacokinetic parameters were determined. Mean time elapsed to peak concentration (Tmax) was less than 2 hours for each regimen. The ratio (regimen A:regimen B) of peak concentration (Cmax) means and area under the curve (AUC)0-infinity means were 0.889 and 0.944, respectively. (AUC0-infinity is the sum of AUC0-t and AUCt-infinity, where AUC0-t is the area under the plasma concentration-time curve from time 0 to the time of the last measurable or nonzero concentration as computed by using the trapezoidal rule, and AUCt-infinity is computed as the last nonzero concentration divided by the terminal phase rate constant.) No statistically significant differences (P < or = 0.05) in Tmax, Cmax, and AUC0-infinity were detected between regimens. These data indicate similar bioavailabilities between the two regimens. Lansoprazole granules contained in a standard capsule dosage formulation may be removed and placed directly into applesauce and administered to appropriate patients.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMedDate not supplied

Lansoprazole: administration of the contents of a capsule dosage formulation through a nasogastric tube.

A single-dose, open-label, randomized, crossover bioavailability study was conducted in 24 healthy adult male volunteers to assess an alternative method of administration of lansoprazole capsules. The results of 22 subjects were analyzed. Subjects received regimen A (granules from a 30-mg capsule mixed with apple juice and administered through a nasogastric tube) or regimen B (an intact 30-mg capsule) during the first study period. The regimens were reversed during the second period 1 week later. Blood samples were obtained over 12 hours and pharmacokinetic variables were determined. No statistically significant differences in mean time elapsed to peak concentration, mean peak concentration, area under the curve (AUC)0-t, and AUC0-infinity were detected between regimens by using analysis of variance. Bioavailability was assessed by the 90% confidence interval of the two one-sided tests on the natural logarithm of AUC. The 90% confidence interval for the AUCzero-infinity ratio was 0.955 to 1.140 for regimens A to B. These results indicate similar bioavailabilities between the two regimens and demonstrate that lansoprazole capsules may be administered by mixing the capsule contents with apple juice for administration through a nasogastric tube.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMedDate not supplied

Metabolism and disposition of clarithromycin in man.

The metabolic fate and pharmacokinetics of clarithromycin following a single 250- or 1200-mg oral dose of 14C-clarithromycin were studied in six healthy adult males. Peak plasma levels of clarithromycin averaged 0.6 microgram/ml after the low dose and 2.7 micrograms/ml after the high dose. The AUC of clarithromycin increased 13-fold, with the 4.8-fold increase in dose, while the plasma half-life increased from 4.4 hr to 11.3 hr. The major metabolite in plasma and urine was the microbiologically active 14-hydroxylated-R epimer of clarithromycin. After 5 days, a mean of 38% of the low dose (18% as clarithromycin) and 46% of the high dose (29% as clarithromycin) was recovered in the urine, with approximately one-third eliminated during the first 24 hr. The nature of the urinary and fecal metabolites revealed the involvement of three metabolic pathways, viz. 1) hydroxylation at the 14-position to form the R and S epimers, 2) N-demethylation, and 3) hydrolysis of the cladinose sugar. Secondary metabolism via these pathways was also evident. The overall recovery of metabolites, but not total radioactivity, decreased 42% after the high dose. The nonlinear pharmacokinetic behavior of clarithromycin and the decrease in metabolite production suggest that clarithromycin metabolism can be saturated at high doses.

Adult↗