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BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone

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ClinicalTrials.gov Identifier: NCT01662674
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 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/Pharmacodynamics of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered in Healthy Male Volunteers
Study Start Date : October 2012
Primary Completion Date : November 2012
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: G+M
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
Drug: gemigliptin and metformin HCl extended release
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
Experimental: C
Combination of gemigliptin50mg/metformin HCl extended release 1000mg
Drug: gemigliptin/metformin HCl extended release
Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.


Outcome Measures

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

  2. Cmax [ Time Frame: up to 48h post-dose ]
    To evaluate Cmax of gemigliptin and metformin


Secondary Outcome Measures :
  1. AUEC [ Time Frame: up to 48h post-dose ]
    This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.


Eligibility Criteria

Information from the National Library of Medicine

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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 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)
Contacts and Locations

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): NCT01662674


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01662674     History of Changes
Other Study ID Numbers: LG-DMCL002
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs