BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 500mg in Comparison to Each Component Administered Alone
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: gemigliptin/metformin HCl extended release
- Registration Number
- NCT01595880
- Lead Sponsor
- LG Life Sciences
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 29
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description G+M gemigliptin and metformin HCl extended release Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg C gemigliptin/metformin HCl extended release Combination of gemigliptin50mg/metformin HCl extended release 500mg
- Primary Outcome Measures
Name Time Method AUClast, Cmax up to 48h post-dose To evaluate AUClast and Cmax of gemigliptin and metformin
- Secondary Outcome Measures
Name Time Method AUCinf, Tmax, t1/2, CL/F, metabolic ratio 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of