NCT02955498

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

A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	Sevikar tab. 10/40mg	Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state
DRUG	Lodivikar tab. 5/40mg	Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2016-11-04
• Last updated: 2016-11-04

Locations

1 site across 1 country: South Korea