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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938262

Enrollment

Registered

2009-07-13

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2009-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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

Interventions

DRUGFimasartan, Ketoconazole, Rifampicin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026