Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
- Registration Number
- NCT01671020
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- age: 20 - 55 years
- body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
- 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 90 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 (T)(R) Fimasartan Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg (R)(T) Fimasartan Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg
- Primary Outcome Measures
Name Time Method AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl, PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of