NCT01133431

The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study

• 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

To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.

Conditions

• Healthy Male Volunteer

Interventions

Type	Name	Description
DRUG	CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet	From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.
DRUG	CKD-501 placebo tablet, Glimepiride 4 mg tablet	From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2010-05-28
• Last updated: 2010-12-10

Locations

1 site across 1 country: South Korea