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

Boryung

Status and phase

Completed

Phase 1

Conditions

Essential Hypertension

Treatments

Drug: Hydrochlorothiazide

Drug: Fimasartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00923533

A657-BR-CT-103

Details and patient eligibility

About

To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

Full 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.

Enrollment

34 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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