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

Dong-A Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Udenafil; Drug: Udenafil+Dapoxetine; Drug: Dapoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928563

DA8159_DIP_I

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Dapoxetine

Experimental group

Description:

Dapoxetine is administered

Treatment:

Drug: Dapoxetine

Udenafil

Experimental group

Description:

Udenafil is administered

Treatment:

Drug: Udenafil

Udenafil and Dapoxetine

Experimental group

Description:

Udenafil and Dapoxetine are co-administered

Treatment:

Drug: Udenafil+Dapoxetine