Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03390465

Enrollment

Registered

2018-01-04

Start date

2017-12-15

Completion date

2018-01-30

Last updated

2018-08-10

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

Conditions

Drug-Drug Interaction

Brief summary

The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.

Interventions

DRUGFimasartan/Amlodipine combination drug, Hydrochlorothiazide

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* A healthy Male adults aged 19-50 years

Exclusion criteria

* History or presence of clinically significant medical or psychiatric condition or disease. * Hypersensitivity to ingredient of IP and other medication, food. * Participation in any other study within 3months. * History of whole blood donation within 2months and Apheresis 1month.

Design outcomes

Primary

Measure	Time frame	Description
Cmax	0~48hours after medication	Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

Secondary

Measure	Time frame	Description
AUCt	0~48hours after medication	AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide

Countries

South Korea

Outcome results

None listed

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