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A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers

Diabetes Mellitus, Type II Clinical Trial

Official title:
A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500 mg in Healthy Male Volunteers

Clinical Trial Summary

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.

Clinical Trial Description

To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.

Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glucophage XR Tab. 500mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T

Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02685774
Study type Interventional
Source Chong Kun Dang Pharmaceutical
Contact
Status Completed
Phase Phase 1
Start date February 2016
Completion date April 2016
View Details
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