A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
NCT ID: NCT01007409
Last Updated: 2009-12-24
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
24 participants
INTERVENTIONAL
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Group B
Period 1: fed control → Period 2: fasted control
Fimasartan
Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast
Group A
Period 1: fasted control → Period 2: fed control
Fimasartan
Period 1: administration of fimasartan 240mg at 9:00am, without the breakfast Period 2: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast
Interventions
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Fimasartan
Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast
Fimasartan
Period 1: administration of fimasartan 240mg at 9:00am, without the breakfast Period 2: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast
Eligibility Criteria
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Inclusion Criteria
* sex: male
* body weight: greater than 55 kg
* written informed consent
Exclusion Criteria
* 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
* abnormal diet which could affect drug absorption or metabolism
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day
* participation in a clinical trial during the last 60 days prior to the start of the study
20 Years
45 Years
MALE
Yes
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Boryung
Other Identifiers
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A657-BR-CT-111
Identifier Type: -
Identifier Source: org_study_id