NCT02685774

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg	Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T oral administration
DRUG	CKD-395 0.25/500mg	CKD-395 0.25/500mg 2T oral administration

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2016-02-19
• Last updated: 2017-08-09

Locations

1 site across 1 country: South Korea