A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).

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

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age between 19 to 45, healthy male subjects(at screening)

• Body weight between 55kg - 90kg, BMI between 18.0 - 27.0

• FPG 60-125mg/dL glucose level(at screening)

• Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

• Volunteer 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)

• Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)

• Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction

• Subject who already participated in other trials in 2 months

• Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion