Clincosm LogoSign in Get a demo

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

Sponsor
Dong-A Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01928563
Collaborator
Dong-A ST Co., Ltd. (Industry)
24
Enrollment
1
Location
3
Arms
3
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine in Healthy Male Subjects
Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapoxetine

Dapoxetine is administered

Drug: Dapoxetine
Other Names:
  • Brand name : Priligy
  • Dapoxetine is administered

    		•
    Experimental: Udenafil

    Udenafil is administered

    Drug: Udenafil
    Other Names:
  • Brand name : Zydena
  • Code name : DA-8159
  • Udenafil is administered

    		•
    Experimental: Udenafil and Dapoxetine

    Udenafil and Dapoxetine are co-administered

    Drug: Udenafil+Dapoxetine
    Other Names:
  • Udenafil and Dapoxetine are co-adminstered

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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 Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Songpa-gu Korea, Republic of 138-786

    Sponsors and Collaborators

    • Dong-A Pharmaceutical Co., Ltd.
    • Dong-A ST Co., Ltd.

    Investigators

    • Principal Investigator: Kyun-Seop Bae, M.D., Ph.D., Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01928563
    Other Study ID Numbers:
    • DA8159_DIP_I
    First Posted:
    Aug 26, 2013
    Last Update Posted:
    Aug 26, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Udenafil

    Study Results

    No Results Posted as of Aug 26, 2013