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Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers

NCT02648854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-02-08

No results posted yet for this study

Summary

This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.

Conditions

  • Diabetes Mellitus, Type II

Interventions

DRUG

CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T

administered CKD-395 0.5/1000mg 1T to oral (fasting condition)

DRUG

CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T

administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • South Korea

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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 NCT02648854 on ClinicalTrials.gov