Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine in Healthy Male Subjects

This study is designed to investigate the pharmacokinetic drug interaction between Udenafil and Dapoxetine in healthy male subjects

Design : Randomized, open-label, 3-treatment, 6-sequence, 3-period crossover study

Investigational Product : Udenafil, Dapoxetine

Inclusion Criteria:

• Male volunteers in the age between 20 and 45 years old at screening
• 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 clinically significant disease or kidney, liver and biliary system, digestive system, respiratory, musculoskeletal, endocrine, neurological psychiatric blood and tumor system, cardiovascular system, etc.
• 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)