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
  Purpose

To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: Fimasartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

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

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: October 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group B
Period 1: fed control → Period 2: fasted control
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
Active Comparator: Group A
Period 1: fasted control → Period 2: fed control
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

  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
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Choi, Director, Boryung
ClinicalTrials.gov Identifier: NCT01007409     History of Changes
Other Study ID Numbers: A657-BR-CT-111
Study First Received: November 2, 2009
Last Updated: December 23, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Boryung Pharmaceutical Co., Ltd:
To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers

ClinicalTrials.gov processed this record on April 23, 2014