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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014