Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

NCT03648333 Phase 1 COMPLETED

To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults

Details

Lead sponsor	Hanlim Pharm. Co., Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	27
Start date	2013-12
Completion	2014-06

Conditions

• Healthy Male Subjects

Interventions

• Exforge tab. 10/160mg
• Lodivixx tab. 5/160mg

Primary outcomes

• Cmax (maximum concentration) — 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour
• AUC(area under curve) — 0 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 3.5 hour, 4 hour, 4.5 hour, 5 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour, 72 hour