Status:
COMPLETED
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
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Kyungpook National University Hospital
Seoul National University Hospital
Conditions:
Essential Hypertension
Eligibility:
MALE
19+ years
Phase:
PHASE1
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 \~ ...
Eligibility Criteria
Inclusion
- age
- young: 19-45 years
- elderly: more than 65 years
- sex: male
- body weight: greater than 55 kg
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00937534
Start Date
January 1 2009
End Date
August 1 2009
Last Update
November 4 2009
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