NCT03629067

Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Treatment T	Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
DRUG	Treatment R	Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Timeline

• Start date: 2018-09-13
• Primary completion: 2018-11-29
• Completion: 2018-12-27
• First posted: 2018-08-14
• Last updated: 2019-01-10

Locations

1 site across 1 country: South Korea