A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
- Registration Number
- NCT00961025
- Lead Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 110
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - DA-1229 DA-1229 DA-1229
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerance of DA-1229 up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study)
Trial Locations
- Locations (1)
Clinical Trials Center, Seoul National University Hospital
🇰🇷Seoul, Chongo-Gu, Yon-Gon Dong, Korea, Republic of