Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01747083
First received: November 30, 2012
Last updated: October 22, 2013
Last verified: October 2013

November 30, 2012
October 22, 2013
January 2013
March 2013   (final data collection date for primary outcome measure)
  • AUClast [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ]
    To evaluate AUClast of gemigliptin and metformin
  • Cmax [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ]
    TO evaluate Cmax of gemigliptin and metformin
Same as current
Complete list of historical versions of study NCT01747083 on ClinicalTrials.gov Archive Site
  • AUCinf [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ]
    To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin)
  • Tmax [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
    To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
  • t1/2 [ Time Frame: up to 48 h post-dose ] [ Designated as safety issue: No ]
    To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
  • Cmax [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
    To evaluate Cmax of LC15-0636(active metabolite of gemigliptim)
  • AUClast [ Time Frame: up to 48h post-dose ] [ Designated as safety issue: No ]
    To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)
Same as current
Not Provided
Not Provided
 
Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)
A Randomized, Open Label, Single Dose, Crossover Study to Investigate Food-effect Bioavailability of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)Under Fed and Fasting Conditions in Healthy Male Volunteers

This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Type 2 Diabetes
Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
  • Experimental: A
    FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition
    Intervention: Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
  • Experimental: B
    FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition
    Intervention: Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 20 to 45, healthy male subjects(at screening)
  • BMI between 19.0 - 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 90 days
  • Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently.
  • Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01747083
LG-DMCL003
Not Provided
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
October 2013

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