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A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components

NCT01780051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-05-15

No results posted yet for this study

Summary

This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Repaglinide/Metformin combination, Repaglinide, Metformin

Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1. Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2.

DRUG

Repaglinide/Metformin combination, Repaglinide, Metformin

Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 1. Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 2.

Sponsors & Collaborators

  • Dalim BioTech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Min-Gul Kim, doctor · Chounbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • South Korea

Study Locations

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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 NCT01780051 on ClinicalTrials.gov