A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT00923533
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 34
- age: 20 - 45 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A Fimasartan Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day) Part B Hydrochlorothiazide Hydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method