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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Glimepiride

Criteria

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