Status:
COMPLETED
Phase I Study to Investigate the Alcohol Interaction of DA8159
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Healthy Volunteers
Erectile Dysfunction
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
This study is designed to to investigate the effects of alcohol on the pharmacokinetics of Udenafil tablet in healthy male volunteers
Eligibility Criteria
Inclusion
- Adult males aged 19 to 55 years at screening.
- Subjects with body weight ≥ 55 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Exclusion
- Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
- Subjects with hypotension or hypertension.
- Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01241032
Start Date
June 1 2006
Last Update
November 16 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea