A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial 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

LG Chem1 site in 1 country70 target enrollmentDecember 13, 2017

InterventionsCombination of gemigliptin/metformin HCl sustained release 50/1000mg Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

DrugsCombination of gemigliptin/metformin HCl sustained release 50/1000mg Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

Overview

Phase: Phase 1
Intervention: Combination of gemigliptin/metformin HCl sustained release 50/1000mg
Conditions: Healthy Male Volunteers
Sponsor: LG Chem
Enrollment: 70
Locations: 1
Primary Endpoint: AUClast
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 13, 2017

End Date

January 12, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

LG Chem

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

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

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

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

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