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

Study Overview
=================
Brief 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

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

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: Dapoxetine
* Drug: Udenafil
* Drug: Udenafil+Dapoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapoxetine<br>Dapoxetine is administered | Drug: Dapoxetine<br> <br> * Other names: Dapoxetine is administered;|
| Experimental: Udenafil<br>Udenafil is administered | Drug: Udenafil<br> <br> * Other names: Udenafil is administered;|
| Experimental: Udenafil and Dapoxetine<br>Udenafil and Dapoxetine are co-administered | Drug: Udenafil+Dapoxetine<br> <br> * Other names: Udenafil and Dapoxetine are co-adminstered;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |