Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg

Phase 1 Completed 33 enrolled Handok Inc.

RandomizedCrossoverOpen-labelBasic science

Summary

The pharmacokinetics of glimepiride and metformin will be compared after single dose intake of both combinations in order to answer to the following questions: * Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg? * What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?

Timeline

Start: 2008-10
Primary completion: 2008-11
Completion: 2009-04

Publications

Shin KH, Kim SE, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. Pharmacokinetic comparison of a new sustained-release formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther. 2011 Nov;33(11):1809-18. doi: 10.1016/j.clinthera.2011.10.003. Epub 2011 Oct 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
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.