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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01595880
First received: May 8, 2012
Last updated: November 16, 2012
Last verified: November 2012

May 8, 2012
November 16, 2012
December 2012
December 2012   (final data collection date for primary outcome measure)
  • AUClast [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
    To evaluate AUClast of gemigliptin and metformin
  • Cmax [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
    To evaluate Cmax of gemigliptin and metformin
Same as current
Complete list of historical versions of study NCT01595880 on ClinicalTrials.gov Archive Site
AUEC [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
This parameter is been used to measure pharmarcodynamic characters of gemigliptin and metformin, the supression rate of DPP4 activity.
Same as current
Not Provided
Not Provided
 
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
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 500mg in Comparison to Each Component Administered Alone in Healthy Male Volunteers

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
28
January 2013
December 2012   (final data collection date for primary outcome measure)

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)
Male
20 Years to 45 Years
Yes
Contact: Jong Hyuk Jung, MS 82-2-6924-3120 jiyungbori@lgls.com
Korea, Republic of
 
NCT01595880
LG-DMCL001
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
LG Life Sciences
November 2012

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