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

Phase 1

• Conditions: Healthy Male Subjects
• Interventions: Drug: Udenafil+Dapoxetine; Drug: Dapoxetine; Drug: Udenafil

• Registration Number: NCT01928563
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Last Update Submitted: 2013-08-21
• Study First Posted: 2013-08-26
• Last Update Posted: 2013-08-26
• Study Start: 2013-09
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Udenafil and Dapoxetine	Udenafil+Dapoxetine	Udenafil and Dapoxetine are co-administered
Dapoxetine	Dapoxetine	Dapoxetine is administered
Udenafil	Udenafil	Udenafil is administered

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of