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NCT01928563 Clinical Trial

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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01928563
Other study ID # DA8159_DIP_I
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received August 21, 2013
Last updated August 21, 2013
Start date September 2013
Est. completion date December 2013

Study information
Verified date August 2013
Source Dong-A ST Co., Ltd.
Contact Yong-Goo Bae, MSc
Phone +82-2-920-8521
Email byg@donga.co.kr
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dapoxetine

• Udenafil

• Udenafil+Dapoxetine

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Songpa-gu

Sponsors (2)
Lead Sponsor Collaborator
Dong-A Pharmaceutical Co., Ltd. Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
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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