Phase I Study to Investigate the Alcohol Interaction of DA8159
NCT ID: NCT01241032
Last Updated: 2010-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Udenafil
Udenafil 200mg
Udenafil
200mg Single Oral Dose of
Udenafil + Alcohol
Udenafil 200mg + Alcohol
Udenafil
200mg Single Oral Dose of
Alcohol
Alcohol 39g / 240ml
Interventions
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Udenafil
200mg Single Oral Dose of
Alcohol
Alcohol 39g / 240ml
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
19 Years
55 Years
MALE
Yes
Sponsors
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Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Dong-A Pharmaceutical Co., Ltd.
Principal Investigators
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Kyun-Seop Bae, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Related Links
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Clinical Research Center, Asan Medical Center
Other Identifiers
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2006-0086
Identifier Type: -
Identifier Source: org_study_id