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

NCT01928563 — Phase 1, Unknown, 24 participants, Dong-A Pharmaceutical Co., Ltd.

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

Registry	NCT01928563
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Dong-A Pharmaceutical Co., Ltd. (Industry); collaborators: Dong-A ST Co., Ltd.
Conditions	Healthy Male Subjects
Interventions	Dapoxetine, Udenafil, Udenafil+Dapoxetine (Drug)
Dates	start 2013-09-01, primary completion 2013-12-01 (estimated), completion 2013-12-01 (estimated), first posted 2013-08-26, last updated 2013-08-26
Locations	1 site in South Korea

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Dapoxetine	Experimental	Drug: Dapoxetine	Dapoxetine is administered
Udenafil	Experimental	Drug: Udenafil	Udenafil is administered
Udenafil and Dapoxetine	Experimental	Drug: Udenafil+Dapoxetine	Udenafil and Dapoxetine are co-administered

Dapoxetine (Drug), also known as Brand name : Priligy, Dapoxetine is administered
Udenafil (Drug), also known as Brand name : Zydena, Code name : DA-8159, Udenafil is administered
Udenafil+Dapoxetine (Drug), also known as Udenafil and Dapoxetine are co-adminstered

+Outcome measures

Primary outcomes

Cmax and AUClast of Udenafil and Dapoxetine [Blood gathering point : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)]

Secondary outcomes

AUC0-00, Tmax, T1/2β of Udenafil and Dapoxetine AUClast, Cmax, Tmax, t1/2β of DA-8164(major metabolite of Udenafil) and Desmethyl dapoxetine(major metabolite of Dapoxetine) [0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)]

+Eligibility

Sex: Male, ages: 20 Years to 45 Years, 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)

+Locations (1)

Facility	City	Country	Status
Asan Medical Center	Seoul, Songpa-gu	South Korea

+Investigators

Kyun-Seop Bae, M.D., Ph.D., Principal investigator, Asan Medical Center