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

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ClinicalTrials.gov Identifier: NCT00991705
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : October 8, 2009
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Atorvastatin Drug: Fimasartan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991705


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

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
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors