drugset / Trial / NCT03648333

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)

NCT03648333

Phase 1 Completed 27 enrolled Hanlim Pharm. Co., Ltd.
RandomizedParallel-groupOpen-labelBasic science

Summary

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

Timeline

Start
2013-12
Primary completion
2014-02
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 10 mg Oral
Subject S-amlodipine Unknown 5 mg Oral
Comparator Valsartan Small molecule 160 mg Oral

Indications

No indication recorded.