A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of each drug, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001173
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 64
•Age between 20 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 in 2 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
- Secondary Outcome Measures
Name Time Method