NCT02648854

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

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

• 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 investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.

Detailed description

To healthy male subjects of 16, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Group 1: CKD-395 0.5/1000mg 1T(Fasting) / CKD-395 0.5/1000mg 1T(Fed) Group 2: CKD-395 0.5/1000mg 1T(Fed) / CKD-395 0.5/1000mg 1T(Fasting) Pharmacokinetic blood samples are collected up to 48hrs. Investigate the effect of food on the pharmacokinetic characteristics of CKD-395

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2016-01-07
• Last updated: 2016-02-08

Locations

1 site across 1 country: South Korea