NCT00934323

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

An Open, Randomized, Two-Treatment, Crossover Study to Assess the Dose Proportionality of Glimepiride Between Amaryl M SR 1/500mg and 2/500mg (Glimepiride-Metformin Fixed Dose Combination Tablet) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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?

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amaryl M SR 1/500 mg	single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group
DRUG	Amaryl M SR 2/500 mg	single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-11-01
• Completion: 2009-04-01
• First posted: 2009-07-08
• Last updated: 2009-07-08

Locations

1 site across 1 country: South Korea