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

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00991705
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Essential Hypertension
Drug: Atorvastatin
Drug: Fimasartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Enrollment: 28
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group B
Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)
Drug: Atorvastatin Drug: Fimasartan
Group A
Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)
Drug: Atorvastatin Drug: Fimasartan

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991705

Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Study Chair: Kyung-Sang Yu, MD Seoul National University Hospital
  More Information

No publications provided by Boryung Pharmaceutical Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Choi, Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00991705     History of Changes
Other Study ID Numbers: A657-BR-CT-109
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan, Atorvastatin

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014