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

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: Combination of gemigliptin/metformin HCl sustained release 50/1000mg; Drug: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg

• Registration Number: NCT03355014
• Lead Sponsor: LG Chem

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-28
• Study Start: 2017-12-13
• Primary Completion: 2018-01-12
• Study Completion: 2018-01-12
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gemigliptin+Metformin combination therapy group	Combination of gemigliptin/metformin HCl sustained release 50/1000mg	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
Gemigliptin and Metformin coadministration therapy group	Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg	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

Primary Outcome Measures

Name	Time	Method
AUClast	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)	To evaluate AUClast of gemigliptin and metformin
Cmax	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)	To evaluate Cmax of gemigliptin and metformin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of