A Study to Assess Food Effect 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:
NCT01007409
First received: November 2, 2009
Last updated: December 23, 2009
Last verified: December 2009

November 2, 2009
December 23, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01007409 on ClinicalTrials.gov Archive Site
Not Provided
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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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01007409
A657-BR-CT-111
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