Study 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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: Fimasartan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers. |
- Cmax, AUClast, tmax, t1/2 [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 22 |
| Study Start Date: | January 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Part A
Young male healthy volunteer
|
Drug: Fimasartan
Fimasartan 240mg/day
|
|
Active Comparator: Part B
Elderly male healthy volunteer
|
Drug: Fimasartan
Fimasartan 240mg/day
|
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
age
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Choi, Director, Boryung Pharm Co., Inc |
| ClinicalTrials.gov Identifier: | NCT00937534 History of Changes |
| Other Study ID Numbers: | A657-BR-CT-104 |
| Study First Received: | July 6, 2009 |
| Last Updated: | November 2, 2009 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Boryung Pharmaceutical Co., Ltd:
|
Fimasartan healthy elderly and young male volunteer pharmacokinetic |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013