clinical trial · NCT00835991
Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed
Teva Pharmaceuticals USA·phase1·completed·n = 60
HealthyGlyburide/Metformin 5 mg/500 mg TabletsGlucovance® 5 mg/500 mg Tablets
brief summary
The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under fed conditions.
started
Feb 1, 2003
primary completion
Feb 1, 2003
completion
Feb 1, 2003
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
Randomized, 2-Way Crossover, Bioequivalence Study of Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets and Glucovance® 5 mg/500 mg Film-Coated Tablets in Healthy Subjects Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol