A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

An Open-label, Multiple-dosing, Crossover, and Parallel Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00923533

Enrollment

Registered

2009-06-18

Start date

2009-03-31

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

Keywords

Fimasartan, Drug interaction

Brief summary

To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

Detailed description

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20 mg \ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose. A open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug interaction between fimasartan and hydrochlorothiazide. 34 male healthy volunteers were enrolled during 2 months. In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day. In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.

Interventions

DRUGFimasartan

Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day)

DRUGHydrochlorothiazide

Hydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day)

Study design

Allocation

NON_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 and hydrochlorothiazide * 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
AUC, Cmax, Tmax, CL/F	0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day

Outcome results

None listed

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