Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects

LG Life Sciences

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Glimepiride

Drug: Gemigliptin and Glimepiride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01768455

LG-DPCL013

Details and patient eligibility

About

The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.

Enrollment

27 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 18 - 27 (at screening)
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

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.(gemigliptin, glimepiride, 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