MedTrace Logo

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

NCT00934323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2009-07-08

No results posted yet for this study

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

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

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
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-11-30
Completion
2009-04-30

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT00934323 on ClinicalTrials.gov