Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

NCT ID: NCT02387554

Last Updated: 2015-06-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Detailed Description

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Conditions

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Hypertension(HTN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HGP0904+HGP0608+HGP1405

amlodipine + losartan + chlorthalidone

Group Type EXPERIMENTAL

HGP0904

Intervention Type DRUG

HGP0608

Intervention Type DRUG

HGP1405

Intervention Type DRUG

HGP0904

amlodipine

Group Type ACTIVE_COMPARATOR

HGP0904

Intervention Type DRUG

HGP0608

losartan

Group Type ACTIVE_COMPARATOR

HGP0608

Intervention Type DRUG

HGP1405

chlorthalidone

Group Type ACTIVE_COMPARATOR

HGP1405

Intervention Type DRUG

Interventions

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HGP0904

Intervention Type DRUG

HGP0608

Intervention Type DRUG

HGP1405

Intervention Type DRUG

Other Intervention Names

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amlodipine losartan chlorthalidone

Eligibility Criteria

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Inclusion Criteria

* 19\~45 years old
* Healthy men

Exclusion Criteria

* Gastroentestinal disease affecting drug absorption
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-ALCH-101

Identifier Type: -

Identifier Source: org_study_id

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