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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Irbesartan

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