An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.
Overview
- Phase
- Phase 1
- Intervention
- Fimasartan
- Conditions
- Essential Hypertension
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 22
- Primary Endpoint
- Cmax, AUClast, tmax, t1/2
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.
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, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers. 22 male healthy volunteers were enrolled during 2 months. In part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration. In part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •young: 19-45 years
- •elderly: more than 65 years
- •sex: male
- •body weight: greater than 55 kg
Exclusion Criteria
- •patients with contraindication to angiotensin II receptor antagonist.
- •patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
- •patients with history or diseases which might affect absorption of the drug
- •patients with HIV, type B or C hepatitis
- •smokers of 20 or more cigarettes per day
Arms & Interventions
Part A
Young male healthy volunteer
Intervention: Fimasartan
Part B
Elderly male healthy volunteer
Intervention: Fimasartan
Outcomes
Primary Outcomes
Cmax, AUClast, tmax, t1/2
Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h