Status:
UNKNOWN
Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-12...
Eligibility Criteria
Inclusion
- Healthy males
- Age 18 to 55
- BMI 18.0 to 30.0 kg/㎡
Exclusion
- History of any drug or alcohol abuse in the past 2years
- Regular alcohol consumption nin males \>21 units per week
- Current smokers and those who have smoked within the last 12months
- Radiation Exposure
- Positive drugs of abuse test result
- Positive HBsAg, HCV Ab, HIV results
- Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
- Clinically significant allergy
- Donation of loss of blood within the previous 3 months
- Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02267902
Start Date
September 1 2014
End Date
January 1 2015
Last Update
October 20 2014
Active Locations (1)
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1
Quotient Clinical
Nottingham, Ruddington, United Kingdom