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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991705
• Other study ID #: A657-BR-CT-109
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2009
• Last updated: October 7, 2009
• Start date: July 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Atorvastatin

• Fimasartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd