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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))

• Registration Number: NCT01747083
• Lead Sponsor: LG Life Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Study Start: 2013-01
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))	FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition
A	FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))	FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition

Primary Outcome Measures

Name	Time	Method
AUClast	up to 48 h post-dose	To evaluate AUClast of gemigliptin and metformin
Cmax	up to 48 h post-dose	TO evaluate Cmax of gemigliptin and metformin

Secondary Outcome Measures

Name	Time	Method
Tmax	up to 48h post-dose	To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
t1/2	up to 48 h post-dose	To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim)
AUCinf	up to 48 h post-dose	To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin)
AUClast	up to 48h post-dose	To evaluate AUClast of LC15-0636(active metabolite of gemigliptim)
Cmax	up to 48h post-dose	To evaluate Cmax of LC15-0636(active metabolite of gemigliptim)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of