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Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501

NCT ID: NCT03089112

Last Updated: 2022-11-10

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-06-16

Brief Summary

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A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

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Detailed Description

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Conditions

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Healthy Male Volunteers

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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Seguence 1

Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501

Group Type EXPERIMENTAL

HGP1607

Intervention Type DRUG

Take it once per period

HGP1501

Intervention Type DRUG

Take it once per period

HGP1607+HGP1501

Intervention Type DRUG

Take it once per period

Seguence 2

Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501

Group Type EXPERIMENTAL

HGP1607

Intervention Type DRUG

Take it once per period

HGP1501

Intervention Type DRUG

Take it once per period

HGP1607+HGP1501

Intervention Type DRUG

Take it once per period

Seguence 3

Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501

Group Type EXPERIMENTAL

HGP1607

Intervention Type DRUG

Take it once per period

HGP1501

Intervention Type DRUG

Take it once per period

HGP1607+HGP1501

Intervention Type DRUG

Take it once per period

Seguence 4

Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607

Group Type EXPERIMENTAL

HGP1607

Intervention Type DRUG

Take it once per period

HGP1501

Intervention Type DRUG

Take it once per period

HGP1607+HGP1501

Intervention Type DRUG

Take it once per period

Seguence 5

Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501

Group Type EXPERIMENTAL

HGP1607

Intervention Type DRUG

Take it once per period

HGP1501

Intervention Type DRUG

Take it once per period

HGP1607+HGP1501

Intervention Type DRUG

Take it once per period

Seguence 6

Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607

Group Type EXPERIMENTAL

HGP1607

Intervention Type DRUG

Take it once per period

HGP1501

Intervention Type DRUG

Take it once per period

HGP1607+HGP1501

Intervention Type DRUG

Take it once per period

Interventions

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HGP1607

Take it once per period

Intervention Type DRUG

HGP1501

Take it once per period

Intervention Type DRUG

HGP1607+HGP1501

Take it once per period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.age 19\~40 years
* 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
* 3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul Asan Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-BAVI-101

Identifier Type: -

Identifier Source: org_study_id

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