Status:
TERMINATED
Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of DWP09031
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 DWP09031 in healthy male volunteers.
Eligibility Criteria
Inclusion
- Healthy adult male subjects aged 20 to 45 years
- The subject has Broca's index ≤ 20%
- 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)
- A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
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 ≥141 mmHg or ≤89 mmHg, and the number of diastolic blood pressure of ≥91mmHg
- A subject who shows the following result in clinical laboratory test:
- AST,ALT\>1.25 times of the upper limit of normal range PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec creatinine clearance ≤ 80mL/min
- Subject who has taken other clinical or licensed medication from another clinical trial within an 90-day 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).
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01522586
Start Date
January 1 2012
End Date
December 1 2013
Last Update
February 13 2014
Active Locations (1)
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1
Inje University College of Medicine Busan Paik Hospital
Busan, Busanjin-gu, South Korea, 614-735