A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
- Registration Number
- NCT01007409
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- age: 20 - 45 years
- sex: male
- body weight: greater than 55 kg
- written informed consent
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Exclusion Criteria
- known allergy to Fimasartan
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A Fimasartan Period 1: fasted control → Period 2: fed control Group B Fimasartan Period 1: fed control → Period 2: fasted control
- Primary Outcome Measures
Name Time Method Cmax, Tmax, AUC, T1/2, CL/F etc. 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours
- Secondary Outcome Measures
Name Time Method