A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects

A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.

Inclusion Criteria:

• 20-45 years healthy male subjects
• Body weight :50-90kg, BMI between 18.5-25
• Blood glucose level of 70-110mg/dL on the FPG test

Exclusion Criteria:

• have a family history of diabetes
• Serum AST(SGOT), ALT(SGPT)>1.25 times upper limit of normal
• Creatinine clearance rate<80mL/min
• show SBP =<100mmHg or >=150mmHg, or DBP=<65mmHg or >=95mmHg, or tachycardia (PR>=100times/min)
• have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
• smokers
• can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects