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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