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

NCT03355014 | Completed Phase 1

• 1 other identifier: LG-DMCL006
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Gemigliptin+Metformin combination therapy group

EXPERIMENTAL

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 and Metformin coadministration therapy group

EXPERIMENTAL

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

Interventions

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

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

Gemigliptin+Metformin combination therapy group

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

Zemiglo 50mg 1 tablet Glucophage XR 2 tablets

Gemigliptin and Metformin coadministration therapy group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32274380 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 28, 2017
• Study Start: December 13, 2017
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: February 22, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)