Status:
UNKNOWN
A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Diabetes Mellitis Type 2
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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 pharmaco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00961025
Start Date
May 1 2009
End Date
March 1 2010
Last Update
August 24 2009
Active Locations (1)
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1
Clinical Trials Center, Seoul National University Hospital
Seoul, Chongo-Gu, Yon-Gon Dong, South Korea, 110-744