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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991705
First Posted: October 8, 2009
Last Update Posted: October 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boryung Pharmaceutical Co., Ltd
October 7, 2009
October 8, 2009
October 8, 2009
July 2009
September 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Not Provided
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A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
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
The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Essential Hypertension
  • Drug: Atorvastatin
  • Drug: Fimasartan
  • Group B
    Atorvastatin (7 days) → Fimasartan + Atorvastatin (7 days)
    Interventions:
    • Drug: Atorvastatin
    • Drug: Fimasartan
  • Group A
    Fimasartan (7 days) → Fimasartan + Atorvastatin (7 days)
    Interventions:
    • Drug: Atorvastatin
    • Drug: Fimasartan
Shin KH, Kim TE, Kim SE, Lee MG, Song IS, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. The effect of the newly developed angiotensin receptor II antagonist fimasartan on the pharmacokinetics of atorvastatin in relation to OATP1B1 in healthy male volunteers. J Cardiovasc Pharmacol. 2011 Nov;58(5):492-9. doi: 10.1097/FJC.0b013e31822b9092.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00991705
A657-BR-CT-109
Yes
Not Provided
Not Provided
Choi, Director, Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
Not Provided
Study Chair: Kyung-Sang Yu, MD Seoul National University Hospital
Boryung Pharmaceutical Co., Ltd
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP