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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
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 24
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition
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
Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747083

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01747083     History of Changes
Other Study ID Numbers: LG-DMCL003
Study First Received: November 30, 2012
Last Updated: October 22, 2013
Health Authority: South korea: Korea Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014