BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

LG Life Sciences37 enrolled

Overview

This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

gemigliptin 50mg, rosuvastatin 20mgDRUG

gemigliptin/rosuvastatin 50/20mg

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 19 to 45, healthy male subjects(at screening) * 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 2months * Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently. * Heavy smokers.(\>10 cigarettes per day)

Locations (1)

Seoul National University Hospital

Seoul, South Korea