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

NCT ID: NCT03390465

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-01-30

Brief Summary

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

Detailed Description

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Conditions

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Drug-Drug Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1(N=6)

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Group Type OTHER

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm2(N=6)

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Group Type OTHER

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm3(N=6)

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Group Type OTHER

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm4(N=6)

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Group Type OTHER

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm5(N=6)

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Group Type OTHER

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Arm6(N=6)

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Group Type OTHER

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Interventions

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Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Intervention Type DRUG

Other Intervention Names

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FAH

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eun-Young Kim

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BR1010

Identifier Type: -

Identifier Source: org_study_id

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