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 after single oral administration in healthy male volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001692
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
•Age between 19 to 45, healthy male subjects(at screening)
•Body weight between 55kg - 90kg, BMI(Body Mass Index) between 18.0 - 27.0
•FPG (Fasting Plasma Glycose) 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
•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 Gastrointestinal(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 or bioequivalence(BE) studies in 3 months
•Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum of concentration (Cmax) of Evogliptin and Metformin ;Area Under Curve(AUC)last of Evogliptin and Metformin
- Secondary Outcome Measures
Name Time Method Time of maximum concentration(Tmax) of Evogliptin and Metformin ;Terminal half-life(t1/2) of Evogliptin and Metformin ;Apparent Clearance(CL/F) of Evogliptin and Metformin ;Area Under Curve(AUC)inf of Evogliptin and Metformin