NCT01747083CompletedPhase 1
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
LG Life Sciences1 site in 1 country24 target enrollmentStarted: January 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUClast
Study Overview
Brief Summary
This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
A
Experimental
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition
Intervention: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets)) (Drug)
B
Experimental
FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition
Intervention: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets)) (Drug)
Outcomes
Primary Outcomes
AUClast
Time Frame: up to 48 h post-dose
To evaluate AUClast of gemigliptin and metformin
Cmax
Time Frame: up to 48 h post-dose
TO evaluate Cmax of gemigliptin and metformin
Secondary Outcomes
- Tmax(up to 48h post-dose)
- t1/2(up to 48 h post-dose)
- AUCinf(up to 48 h post-dose)
- AUClast(up to 48h post-dose)
- Cmax(up to 48h post-dose)
Investigators
Study Sites (1)
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