drugset / Trial / NCT00934817

Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg

NCT00934817

Phase 1 Completed 36 enrolled Handok Inc.
RandomizedCrossoverOpen-labelBasic science

Summary

The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose intake of both combinations in order to answer the following questions: * Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard to the glimepiride component? * Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?

Timeline

Start
2007-03
Primary completion
2007-05
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule 1 mg Oral
Subject Glimepiride Small molecule 2 mg Oral
Subject Metformin Small molecule 500 mg Oral

Indications

No indication recorded.