The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

June 30, 2010

Study Completion Date

August 31, 2010

Conditions
Healthy Male Volunteer
Interventions
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.

Trial Locations (1)

Unknown

The Korea University Anam Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Chong Kun Dang Pharmaceutical

INDUSTRY