NCT01005160

Drug Interaction Between CKD-501 and Metformin

A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.

Detailed description

Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days. In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days. Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Metformin	CKD-501 0.5mg, metformin 1000mg
DRUG	CKD-501	CKD-501 0.5mg, metformin 1000mg

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2009-10-30
• Last updated: 2011-01-12