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

LG Chem70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Male Volunteers

Interventions

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

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

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

Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast

To evaluate AUClast of gemigliptin and metformin

Time frame: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)

Cmax

To evaluate Cmax of gemigliptin and metformin

Time frame: up to 48hrs of post-dose(pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)

Secondary Outcomes

AUEC

This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.

Time frame: up to 48hrs of post-dose (pre-dose, 0.5, 1,1.5,2,3,4,5,6,7,8,10,12,14,24,32,48, post dose at 1d and 8d)

Data from ClinicalTrials.gov

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