A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers

NCT02358824 Phase 1 COMPLETED

A randomized, open-label, single-dose, four-period, two-way, crossover study,

Details

Lead sponsor	Chong Kun Dang Pharmaceutical
Phase	Phase 1
Status	COMPLETED
Enrolment	48
Start date	2015-02
Completion	2015-06

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 144 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 144 hours post dose

Countries

South Korea