Status:
COMPLETED
A Single Dose Study of DWP10292 in Healthy Male Subjects
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of orally administrated DWP10292 in healthy male volunteers.
Eligibility Criteria
Inclusion
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- Healthy adult male subjects aged 20 to 45 years
- The subject has a Body weight ≥ 60 kg and \< 90 kg and Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 27.0 kg/m2
- A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
Exclusion
- A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
- A subject who shows the following result in clinical laboratory test:
- AST,ALT\>1.25 times of the upper limit of normal range
- QTc\>430msec
- T.bil\>1.25 times of the upper limit of normal range
- A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 8 weeks
- Subject who has taken other clinical or licensed medication from another clinical trial within an 8-week period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial).
- Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01423526
Start Date
August 1 2011
End Date
February 1 2012
Last Update
February 25 2014
Active Locations (2)
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1
Seoul National University Hospital
Seoul, Korea, South Korea
2
Seoul National University Hospital
Seoul, South Korea