A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Atorvastatin; Drug: Fimasartan

• Registration Number: NCT00991705
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Last Update Submitted: 2009-10-07
• Study First Posted: 2009-10-08
• Last Update Posted: 2009-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Atorvastatin	Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)
Group B	Fimasartan	Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)
Group A	Atorvastatin	Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)
Group A	Fimasartan	Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)