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

NCT00934817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-07-08

No results posted yet for this study

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?

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Handok Inc.

    lead INDUSTRY

Principal Investigators

  • In-Jin Jang, Professor · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-05-31
Completion
2007-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934817 on ClinicalTrials.gov