A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

Detailed Description
-----------------
Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20 mg   480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose. A open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide. 34 male healthy volunteers were enrolled during 2 months. In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day. In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.

Official Title
-----------------
An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Fimasartan
* Drug: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 45 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: known allergy to Fimasartan and hydrochlorothiazide existing cardiac or hematological diseases existing hepatic and renal diseases existing gastrointestinal diseases acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 2 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part A<br>Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day) | Drug: Fimasartan<br>* Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)<br>|
| Active Comparator: Part B<br>Hydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day) | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Cmax, Tmax, CL/F |  | 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fimasartan, Drug interaction