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
NCT ID: NCT00937534
Last Updated: 2009-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2009-01-31
2009-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part A
Young male healthy volunteer
Fimasartan
Fimasartan 240mg/day
Part B
Elderly male healthy volunteer
Fimasartan
Fimasartan 240mg/day
Interventions
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Fimasartan
Fimasartan 240mg/day
Eligibility Criteria
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Inclusion Criteria
* young: 19-45 years
* elderly: more than 65 years
* sex: male
* body weight: greater than 55 kg
Exclusion Criteria
* 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
19 Years
MALE
Yes
Sponsors
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Kyungpook National University Hospital
OTHER
Seoul National University Hospital
OTHER
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Boryung Pharm Co., Inc
Other Identifiers
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A657-BR-CT-104
Identifier Type: -
Identifier Source: org_study_id
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