BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age between 19 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 3months

• 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)