To Compare the Pharmacokinetics and Safety of CKD-828 80/5mg to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers

NCT02250833 Phase 1 COMPLETED

A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.

Details

Lead sponsor	Chong Kun Dang Pharmaceutical
Phase	Phase 1
Status	COMPLETED
Enrolment	69
Start date	2014-09
Completion	2014-12

Conditions

• Hypertension

Interventions

• CKD-828
• Telmisartan
• S-amlodipine

Primary outcomes

• Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. — up to 168 hours post dose
• AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. — up to 168 hours post dose

Countries

South Korea