Healthy Male Subjects Clinical Trial
Official title:
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
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul | Songpa-gu |
Lead Sponsor | Collaborator |
---|---|
Dong-A Pharmaceutical Co., Ltd. | Dong-A ST Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No | |
Secondary | AUC0-00, Tmax, T1/2ß of Udenafil and Dapoxetine AUClast, Cmax, Tmax, t1/2ß 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) | No |
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