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Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

NCT ID: NCT03629067

Last Updated: 2019-01-10

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2018-12-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacokinetics

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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Sequence A

Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T)

There will be a 14 washout of days between the each period.

Group Type EXPERIMENTAL

Treatment T

Intervention Type DRUG

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

Treatment R

Intervention Type DRUG

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Sequence B

Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R)

There will be a 14 washout of days between the each period.

Group Type EXPERIMENTAL

Treatment T

Intervention Type DRUG

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

Treatment R

Intervention Type DRUG

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Sequence C

Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R)

There will be a 14 washout of days between the each period.

Group Type EXPERIMENTAL

Treatment T

Intervention Type DRUG

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

Treatment R

Intervention Type DRUG

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Interventions

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Treatment T

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

Intervention Type DRUG

Treatment R

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Intervention Type DRUG

Other Intervention Names

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FAH FA/H

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

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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Kyung-sang Yu

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BR1010(BR-FAHC-CT-102)

Identifier Type: -

Identifier Source: org_study_id

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