Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03629067

Enrollment

Registered

2018-08-14

Start date

2018-09-13

Completion date

2018-12-27

Last updated

2019-01-10

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

Conditions

Pharmacokinetics

Keywords

Hypertension

Brief summary

The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.

Interventions

DRUGTreatment T

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

DRUGTreatment R

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* A healthy 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	0~144hours after Medication	Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

Secondary

Measure	Time frame	Description
AUCinf	0~144hours after medication	Area under the plasma concentration versus time curve of Fimasartan, Amlodipine, Hydrochlorothiazide

Countries

South Korea

Outcome results

None listed

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