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Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816

NCT ID: NCT02554136

Last Updated: 2015-09-18

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

2015-07-31

Study Completion Date

2015-08-31

Brief Summary

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The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly

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Detailed Description

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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

HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816

Group Type EXPERIMENTAL

HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Sequence 2

HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918

Group Type EXPERIMENTAL

HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Sequence 3

HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816

Group Type EXPERIMENTAL

HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Sequence 4

HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816

Group Type EXPERIMENTAL

HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Sequence 5

HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816

Group Type EXPERIMENTAL

HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Sequence 6

HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918

Group Type EXPERIMENTAL

HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Interventions

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HGP0918

Intervention Type DRUG

HGP0816

Intervention Type DRUG

HGP0918 + HGP0816

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* Healthy male volunteers, aged 19 to 55 years.
* The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2

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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
* Somenone has a declined kidney function and his eGFR \< 60mL/min/1.73m2
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

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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Inje Busan Paik hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-ROMA-105

Identifier Type: -

Identifier Source: org_study_id

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