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
1 other identifier
interventional
24
1 country
1
Brief Summary
This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Jan 2013
Shorter than P25 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
December 11, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedOctober 24, 2013
October 1, 2013
2 months
November 30, 2012
October 22, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
To evaluate AUClast of gemigliptin and metformin
up to 48 h post-dose
Cmax
TO evaluate Cmax of gemigliptin and metformin
up to 48 h post-dose
Secondary Outcomes (5)
AUCinf
up to 48 h post-dose
Tmax
up to 48h post-dose
t1/2
up to 48 h post-dose
Cmax
up to 48h post-dose
AUClast
up to 48h post-dose
Study Arms (2)
A
EXPERIMENTALFDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition
B
EXPERIMENTALFDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
December 11, 2012
Study Start
January 1, 2013
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
October 24, 2013
Record last verified: 2013-10