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A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007409
First Posted: November 4, 2009
Last Update Posted: December 24, 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
November 2, 2009
November 4, 2009
December 24, 2009
October 2009
November 2009   (Final data collection date for primary outcome measure)
Cmax, Tmax, AUC, T1/2, CL/F etc. [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours ]
Same as current
Complete list of historical versions of study NCT01007409 on ClinicalTrials.gov Archive Site
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A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Fimasartan
    Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast
  • Drug: Fimasartan
    Period 1: administration of fimasartan 240mg at 9:00am, without the breakfast Period 2: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast
  • Active Comparator: Group B
    Period 1: fed control → Period 2: fasted control
    Intervention: Drug: Fimasartan
  • Active Comparator: Group A
    Period 1: fasted control → Period 2: fed control
    Intervention: Drug: Fimasartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
November 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
  • 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
  • abnormal diet which could affect drug absorption or metabolism
  • positive drug or alcohol screening
  • smokers of 10 or more cigarettes per day
  • participation in a clinical trial during the last 60 days 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
 
 
NCT01007409
A657-BR-CT-111
Not Provided
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Not Provided
Choi, Director, Boryung
Boryung Pharmaceutical Co., Ltd
Not Provided
Not Provided
Boryung Pharmaceutical Co., Ltd
December 2009

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