drugset / Trial / NCT00834613

Metformin ER 750 mg Tablets, Fed

NCT00834613 ↗

Phase 1 Completed 32 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.

Timeline

Start
2003-08
Primary completion
2003-08
Completion
2003-08

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 103.45 (90% CI 99.87 to 107.15) NCT00834613 ↗

registry Ratio of the T/R geometric mean x 100 97.63 (90% CI 95.21 to 100.11) NCT00834613 ↗

registry Ratio of the T/R geometric mean x 100 97.63 (90% CI 95.22 to 100.1) NCT00834613 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 750 mg —

Indications

No indication recorded.