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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

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date February 3, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
AUClast, Cmax [ Time Frame: up to 48h post-dose ]
To evaluate AUClast and Cmax of gemigliptin and metformin
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • AUClast [ Time Frame: up to 48h post-dose ]
    To evaluate AUClast of gemigliptin and metformin
  • Cmax [ Time Frame: up to 48h post-dose ]
    To evaluate Cmax of gemigliptin and metformin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: gemigliptin and metformin HCl extended release
    Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day
  • Drug: gemigliptin/metformin HCl extended release
    Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
Study Arms  ICMJE
  • Experimental: G+M
    Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg
    Intervention: Drug: gemigliptin and metformin HCl extended release
  • Experimental: C
    Combination of gemigliptin50mg/metformin HCl extended release 500mg
    Intervention: Drug: gemigliptin/metformin HCl extended release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2015)
29
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2012)
28
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595880
Other Study ID Numbers  ICMJE LG-DMCL001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LG Life Sciences
Study Sponsor  ICMJE LG Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
PRS Account LG Life Sciences
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP