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Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

NCT01443221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-09-29

No results posted yet for this study

Summary

To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

mitiglinide and metformin

Free combination of Mitiglinide 10mg and Metformin 500mg

DRUG

mitiglinide and metformin

Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Sponsors & Collaborators

Principal Investigators

  • Wooseong Hur, MD, PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • South Korea

Study Locations

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Entities

Companies

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 NCT01443221 on ClinicalTrials.gov