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

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747083

LG-DMCL003

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

24 participants in 2 patient groups

A

Experimental group

Description:

FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition

Treatment:

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

B

Experimental group

Description:

FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition

Treatment:

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