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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355014
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: Combination of gemigliptin/metformin HCl sustained release 50/1000mg Drug: Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. AUClast [ 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) ]
    To evaluate AUClast of gemigliptin and metformin

  2. Cmax [ 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) ]
    To evaluate Cmax of gemigliptin and metformin


Secondary Outcome Measures :
  1. AUEC [ 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) ]
    This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355014


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Chem
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03355014    
Other Study ID Numbers: LG-DMCL006
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs