Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

LG Life Sciences

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Irbesartan

Drug: Gemigliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01825850

LG-GBCL001

Details and patient eligibility

About

The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.

Enrollment

30 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria
- Age between 20 to 45, healthy male subjects (at screening)
- BMI between 18 - 27 kg/m2 (at screening)
- Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
- 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 that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- Subject who had drug hypersensitivity reaction.(gemigliptin, irbesartan, aspirin, antibiotics)
- Subject who already admitted in other investigator product in 80 days
- Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently