drugset / Trial / NCT00649454

Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg

NCT00649454

Phase 1 Completed 36 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting conditions.

Timeline

Start
2005-06
Primary completion
2005-06
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Glipizide Small molecule 5 mg Oral
Subject Metformin Small molecule 500 mg Oral

Indications

No indication recorded.