Glimepiride 4 mg Tablets Under Non-Fasting Conditions

Phase 1 Completed 32 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2003-03
Primary completion: 2003-03
Completion: 2003-03

Outcome

Met primary endpoint

registry analysis (unspecified test); Glimepiride vs Amaryl®; Geometric Test/Ref Ratio x 100 102 (90% CI 92.1 to 112) NCT00835172 ↗

registry analysis (unspecified test); Glimepiride vs Amaryl®; Geometric Test/Ref Ratio x 100 101 (90% CI 96.8 to 105) NCT00835172 ↗

registry analysis (unspecified test); Glimepiride vs Amaryl®; Geometric Test/Ref Ratio x 100 103 (90% CI 99.3 to 106) NCT00835172 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glimepiride	Small molecule	4 mg	—

Indications

No indication recorded.