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BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone

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ClinicalTrials.gov Identifier: NCT01595880
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Study Description
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Brief Summary:
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and metformin HCl extended release 500mg in comparison to each component administered alone in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: gemigliptin and metformin HCl extended release Drug: gemigliptin/metformin HCl extended release Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers
Study Start Date : December 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: G+M
Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg
 Drug: gemigliptin and metformin HCl extended release
Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day
Experimental: C
Combination of gemigliptin50mg/metformin HCl extended release 500mg
 Drug: gemigliptin/metformin HCl extended release
Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.


Outcome Measures
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Primary Outcome Measures :
  1. AUClast, Cmax [ Time Frame: up to 48h post-dose ]
    To evaluate AUClast and Cmax of gemigliptin and metformin


Secondary Outcome Measures :
  1. AUCinf, Tmax, t1/2, CL/F, metabolic ratio [ Time Frame: up to 48h post-dose ]
    To evaluate AUCinf, Tmax, t1/2 and CL/F of gemigliptin and metformin, To evaluate AUClast, Cmax and metabolic ratio of gemigliptin metabolite LC15-0636


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20 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)
  • 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, Neurology,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 2months
  • 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)
Contacts and Locations
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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): NCT01595880


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
LG Life Sciences
Investigators
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Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
More Information
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01595880    
Other Study ID Numbers: LG-DMCL001
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs