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BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone

NCT ID: NCT03355014

Last Updated: 2018-02-22

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2018-01-12

Brief Summary

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This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male volunteers.

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COMPLETED PHASE1

Detailed Description

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This study will be conducted in separtes 2 Parts.

Part I is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting condition.

Part II is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fed conditions.

In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects.

the study design and arms are the same in both parts.

Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Gemigliptin+Metformin combination therapy group

Part I (Fasted) Combination therapy of gemigliptin/metformin sustained release 50/1000mg(25/500mg 2tablets), for 1day

Part II (High fat diet) Combination therapy of gemigliptin/metformin sustained release 50/1000mg(25/500mg 2tablets), for 1day

Group Type EXPERIMENTAL

Combination of gemigliptin/metformin HCl sustained release 50/1000mg

Intervention Type DRUG

Gemigliptin/Metformin HCl extended release 25/500mg 2tablets

Gemigliptin and Metformin coadministration therapy group

Part I (Fasted) Coadministration therapy of gemigliptin 50mg and metformin HCL extended relese 1000mg

Part II (High fat diet) Coadministration therapy of gemigliptin 50mg and metformin HCL extended relese 1000mg

Group Type EXPERIMENTAL

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

Intervention Type DRUG

Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

Interventions

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Combination of gemigliptin/metformin HCl sustained release 50/1000mg

Gemigliptin/Metformin HCl extended release 25/500mg 2tablets

Intervention Type DRUG

Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 19 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subjects who are appropriate to conduct study procedure in the decision of investigator
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, meurology, immunology, pulmonary, endocrine, hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 3months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Jin X, Kim E, Huh KY, Hwang I, Cho JY, Yu KS, Lee S. Pharmacokinetics and pharmacodynamics of a fixed-dose combination of gemigliptin/metformin sustained release 25/500 mg compared to the loose combination in healthy male subjects. Transl Clin Pharmacol. 2020 Mar;28(1):43-54. doi: 10.12793/tcp.2020.28.e2. Epub 2020 Mar 30.

Reference Type DERIVED
PMID: 32274380 (View on PubMed)

Other Identifiers

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LG-DMCL006

Identifier Type: -

Identifier Source: org_study_id

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