NCT00934817

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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?

Detailed description

16 subjects were randomized to each of 2 sequence groups which have different treatment order of the study drug in each period. Only healthy volunteers had screening tests such as medical inquiry, physical examination, clinical laboratory test, etc. within 4 weeks (-28d \~ -1d) prior to drug administration (1d) and those determined eligible for this study were selected and randomized between screening and 1 day prior to the first administration of study medication (-1d). Then, the subjects were admitted to the clinical research center of Seoul National University Hospital by 9 p.m. of -1d and then, they were not allowed to take anything except water. After one week of washout period, subjects went on to the second phase of treatment period and were administered according to the treatment order in a crossover way. For the subjects who completed the study, post-study visit tests were performed after a designated time had passed.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-05-01
• Completion: 2007-08-01
• First posted: 2009-07-08
• Last updated: 2009-07-08