clinical trial · NCT00834340
Glimepiride 4 mg Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 32
HealthyGlimepiride 4 mg TabletsAMARYL® 4 mg Tablets
brief summary
The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMARYL® tablets (Aventis) in healthy, adult, non-smoking subjects under fasting conditions.
started
Feb 1, 2003
primary completion
Mar 1, 2003
completion
Mar 1, 2003
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Relative Bioavailability Study of Glimepiride 4 mg Tablets Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol