NCT01330563

Drug-drug Interaction Study (CKD-501, Ketoconazole)

Drug-Drug Interaction Study to Investigate the Effect of Ketoconazole on the Pharmacokinetic Properties of CKD-501 in Healthy Male Volunteer: Open, Randomised, 2-way Crossover, Clinical Trial

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

Summary

The purpose of this study is to assess the effect of Ketoconazole on the pharmacokinetic characteristics of CKD-501 in healthy subject.

Detailed description

From day 1 to day 5, Ketoconazole 200mg is administered twice daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg is co-administered Group 1 patients at period 1. After 28 day-break, period 2 will CKD-501 0.5mg administered on day 5. Period 2 will not Ketoconazole administered. Group 2 is administered in reverse order.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	CKD-501, Ketoconazole	Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-04-07
• Last updated: 2011-06-29

Locations

1 site across 1 country: South Korea