At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Glimepiride 4 mg Tablets +1 moredrug
Likely dose
Glimepiride 4 mg Tabletsfrom record
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A Relative Bioavailability Study of Glimepiride 4 mg Tablets Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Glimepiride 4 mg Tablets and AMARYL® 4 mg Tablets for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed 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 non-fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2003
Primary CompletionMar 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartMar 1, 2003
Primary CompletionMar 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Glimepiride 4 mg Tabletsdrug
1 x 4 mg, single-dose non-fasting
AMARYL® 4 mg Tabletsdrug
1 x 4 mg, single-dose non-fasting