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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Combination of gemigliptin/metformin HCl sustained release 50/1000mg; Gemigliptin/Metformin HCl extended release 25/500mg 2tablets
Experimental: 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	Drug: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg; Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	To evaluate AUClast of gemigliptin and metformin	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUEC	This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.	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)

Collaborators and Investigators

• Sponsor: LG Chem

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: LG-DMCL006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No