Trials / Completed

CompletedNCT02205151

To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets

An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 86 (actual)

Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
Sex: Male
Age: 19 Years – 50 Years
Healthy volunteers: Accepted

Summary

Detailed description

After subjects have signed informed consent voluntarily, they go through screening period for within 21 days. As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day. And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day. At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total). At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

Conditions

Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan
DRUG	Amlodipine
DRUG	Fimasartan/Amlodipine combination

Timeline

Start date: 2014-07-01
Primary completion: 2014-09-01
Completion: 2014-09-01
First posted: 2014-07-31
Last updated: 2014-10-15

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02205151. Inclusion in this directory is not an endorsement.