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CompletedNCT00938262Updated Oct 8, 2009

A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

A Phase 1 interventional study of Fimasartan, Ketoconazole, Rifampicin in Essential Hypertension, sponsored by Boryung Pharmaceutical Co., Ltd. Completed. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-08.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Essential Hypertension
03

In context

Essential Hypertension

527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's enrollment of 24 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • age: 20 - 45 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Fimasartan, Ketoconazole, Rifampicin

    Drug: Fimasartan, Ketoconazole, Rifampicin

Interventions

  • DrugFimasartan, Ketoconazole, Rifampicin

    Fimasartan (1 day) Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day) Rifampicin (9 days) Rifampicin + Fimasartan (1 day)

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00938262
Lead sponsor
Boryung Pharmaceutical Co., Ltd
First posted
Jul 13, 2009
Start date
Apr 2009
Primary completion
Jun 2009
Completion
Aug 2009
Last update
Oct 8, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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