Pharmacokinetics and bioavailability of a metformin/glyburide tablet administered alone and with food.
Two randomized crossover studies were conducted to evaluate the pharmacokinetics (including food effect) of fixed-combination metformin/glyburide tablets. Pharmacokinetics and bioavailability of two strengths (500 mg/2.5 mg and 500 mg/5 mg) of metformin/glyburide tablets were assessed relative to coadministered metformin and glyburide tablets in study 1. The effect of a high-fat meal on the bioavailability of a metformin/glyburide (500 mg/5 mg) tablet was assessed relative to the fasted condition in study 2. The fixed combination metformin/glyburide tablets showed bioequivalence for the metformin component with the reference metformin tablet and comparable bioavailability for the glyburide component with the reference glyburide tablet. Food does not appear to affect the bioavailability of either component to an appreciable extent.
Marathe
P H
PH
Bristol-Myers Squibb Company, Department of Metabolism and Pharmacokinetics, Route 206 and Provinceline Road, Princeton, NJ 08540, USA.
Arnold
M E
ME
Meeker
J
J
Greene
D S
DS
Barbhaiya
R H
RH
D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D018592:Cross-Over Studies; D005260:Female; D018565:Food-Drug Interactions; D005905:Glyburide / Q000493:pharmacokinetics*; D006801:Humans; D007004:Hypoglycemic Agents / Q000493:pharmacokinetics*; D008297:Male; D008687:Metformin / Q000493:pharmacokinetics*; D013607:Tablets
D007004:Hypoglycemic Agents; D013607:Tablets; D008687:Metformin; D005905:Glyburide