A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Overview
The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.
Full Title of Study: “An Open-label, Two-treatment, Two-period, Two-sequence, Crossover Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2009
Interventions
- Drug: Atorvastatin
- Drug: Fimasartan
Arms, Groups and Cohorts
- Other: Group B
- Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)
- Other: Group A
- Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)
Participating in This Clinical Trial
Inclusion Criteria
- age: 20 – 45 years – sex: male – body weight: greater than 55 kg – written informed consent Exclusion Criteria:
- known allergy to Fimasartan and atorvastatin – 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 – positive drug or alcohol screening – smokers of 10 or more cigarettes per day 3 month ago – participation in a clinical trial during the last 2 months prior to the start of the study
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Provider of Information About this Clinical Study
- Choi, Director, Boryung Pharmaceutical Co., Ltd
- Overall Official(s)
- Kyung-Sang Yu, MD, Study Chair, Seoul National University Hospital
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