A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01007409

Enrollment

Registered

2009-11-04

Start date

2009-10-31

Completion date

Unknown

Last updated

2009-12-24

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

Conditions

Healthy

Keywords

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

Brief summary

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

Interventions

DRUGFimasartan

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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 * 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

Design outcomes

Primary

Measure	Time frame
Cmax, Tmax, AUC, T1/2, CL/F etc.	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours

Outcome results

None listed

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