Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine
NCT ID: NCT01928563
Last Updated: 2013-08-26
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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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2013-09-30
2013-12-31
Brief Summary
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Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study
Investigational Product : Udenafil, Dapoxetine
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Dapoxetine
Dapoxetine is administered
Dapoxetine
Udenafil
Udenafil is administered
Udenafil
Udenafil and Dapoxetine
Udenafil and Dapoxetine are co-administered
Udenafil+Dapoxetine
Interventions
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Dapoxetine
Udenafil
Udenafil+Dapoxetine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index(BMI) in the range of 19 to 27 ㎏/㎡
* Sitting position blood pressure down to meet the criteria at the time of screening (90mmHg≤Systolic blood pressure≤140mmHg)
Exclusion Criteria
* History of gastrointestinal diseases or gastrointestinal operation which might affect the study drug absorption
* Clinically significant hypersensitivity or with a history of hypersensitivity reactions to Udenafil, Dapoxetine ingredients that included elements of the same family of drugs, or other medications
* ≥ 1.5 fold of normal upper limit(UNL) in the level of ALT, AST
* Alcohol, excessive intake (\>21 units/week)
* Excessive smoker (\>10 cigarette/day)
20 Years
45 Years
MALE
Yes
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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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, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyun-Seop Bae, M.D., Ph.D.
Role: primary
Other Identifiers
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DA8159_DIP_I
Identifier Type: -
Identifier Source: org_study_id