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Completed

NCT Number: NCT01747083

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))

Drug

Primary outcomes

  1. AUClast

    Time frame: up to 48 h post-dose

    To evaluate AUClast of gemigliptin and metformin

  2. Cmax

    Time frame: up to 48 h post-dose

    TO evaluate Cmax of gemigliptin and metformin

Secondary outcomes

  1. AUCinf

    Time frame: up to 48 h post-dose

    To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin)

  2. Tmax

    Time frame: up to 48h post-dose

    To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)

  3. t1/2

    Time frame: up to 48 h post-dose

    To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)

  4. Cmax

    Time frame: up to 48h post-dose

    To evaluate Cmax of LC15-0636(active metabolite of gemigliptim)

  5. AUClast

    Time frame: up to 48h post-dose

    To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2012
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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