Evaluating the Bioequivalence of HIP1302, HGP1406

NCT ID: NCT02545829

Last Updated: 2016-10-13

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.

Detailed Description

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A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers

Conditions

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Healthy

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 1

HGP1406 → HIP1302

Group Type EXPERIMENTAL

HIP1302

Intervention Type DRUG

Tenofovir 292mg

HGP1406

Intervention Type DRUG

Tenofovir 300mg

Sequence 2

HIP1302 → HGP1406

Group Type EXPERIMENTAL

HIP1302

Intervention Type DRUG

Tenofovir 292mg

HGP1406

Intervention Type DRUG

Tenofovir 300mg

Interventions

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HIP1302

Tenofovir 292mg

Intervention Type DRUG

HGP1406

Tenofovir 300mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers, age 19 to 50 years
* The result of Body Mass Index(BMI) is not less than 18.0 kg/m2, no more than 27.0 kg/m2
* 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

* 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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 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

Principal Investigators

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Kyung-Sang Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-POVI-101

Identifier Type: -

Identifier Source: org_study_id

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