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

LG Life Sciences

Status and phase

Unknown

Phase 1

Conditions

Healthy

Treatments

Drug: gemigliptin and metformin HCl extended release

Drug: gemigliptin/metformin HCl extended release

Study type

Interventional

Funder types

Industry

Identifiers

NCT02670018

LG-DMCL005

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)