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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 34
- Primary Endpoint
- AUC, Cmax, Tmax, CL/F
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Part A
Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)
Intervention: Fimasartan (Drug)
Part B
Hydrochlorothiazide (7day) Hydrochlorothiazide + Fimasartan (7day)
Intervention: Hydrochlorothiazide (Drug)
Outcomes
Primary Outcomes
AUC, Cmax, Tmax, CL/F
Time Frame: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day
Secondary Outcomes
No secondary outcomes reported