A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers

NCT01341392 Phase 1 COMPLETED

The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.

Details

Lead sponsor	Chong Kun Dang Pharmaceutical
Phase	Phase 1
Status	COMPLETED
Enrolment	25
Start date	2011-04
Completion	2011-08

Conditions

• Type 2 Diabetes Mellitus

Interventions

• CKD-501
• amlodiopine
• CKD-501 amlodipine

Primary outcomes

• CKD-501 AUC — Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr
• Amlodipine AUC — Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr

Countries

South Korea