drugset / Trial / NCT02955498

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

NCT02955498

Phase 1 Completed 32 enrolled Hanlim Pharm. Co., Ltd.
RandomizedCrossoverOpen-label

Summary

The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.

Timeline

Start
2014-04
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified Oral
Subject Olmesartan Other / unclassified Oral
Subject S-amlodipine Unknown Oral

Indications

No indication recorded.