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A Study to Evaluate the Effect of Ketoconazole and Rifampicin 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:
NCT00938262
First received: July 10, 2009
Last updated: October 7, 2009
Last verified: October 2009
History of Changes
  Purpose

To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.


Condition Intervention Phase
Essential Hypertension
 Drug: Fimasartan, Ketoconazole, Rifampicin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2 [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fimasartan, Ketoconazole, Rifampicin Drug: Fimasartan, Ketoconazole, Rifampicin

Fimasartan (1 day)

Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day)

Rifampicin (9 days) Rifampicin + Fimasartan (1 day)

  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, ketoconazole and rifampicin
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Choi, Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00938262     History of Changes
Other Study ID Numbers: A657-BR-CT-105
Study First Received: July 10, 2009
Last Updated: October 7, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ketoconazole
Rifampin
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013