Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed

Phase 1 Completed 60 enrolled Teva Pharmaceuticals USA

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2003-02
Primary completion: 2003-02
Completion: 2003-02

Outcome

Met primary endpoint

registry Test/Ref Ratio of LS Means x 100 114.05 (90% CI 107.26 to 121.27) NCT00835991 ↗

registry Test/Ref Ratio of LS Means x 100 100.63 (90% CI 97.59 to 103.76) NCT00835991 ↗

registry Test/Ref Ratio of LS Means x 100 101.36 (90% CI 98.32 to 104.48) NCT00835991 ↗

registry Test/Ref Ratio of LS Means x 100 99.05 (90% CI 94.31 to 104.02) NCT00835991 ↗

registry Test/Ref Ratio of LS Means x 100 96.55 (90% CI 93.85 to 99.32) NCT00835991 ↗

registry Test/Ref Ratio of LS Means x 100 96.44 (90% CI 93.71 to 99.25) NCT00835991 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glyburide	Small molecule	5 mg	—
Subject	Metformin	Small molecule	500 mg	—

Indications

No indication recorded.