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Trial record 3 of 23 for:    priligy

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

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ClinicalTrials.gov Identifier: NCT01928563
Recruitment Status : Unknown
Verified August 2013 by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ).
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2013
Last Update Posted : August 26, 2013
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( 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


Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: Dapoxetine Drug: Udenafil Drug: Udenafil+Dapoxetine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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 Name: Udenafil and Dapoxetine are co-adminstered




Primary Outcome Measures :
  1. Cmax and AUClast of Udenafil and Dapoxetine [ Time Frame: 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) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period) ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928563


Contacts
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Contact: Yong-Goo Bae, MSc +82-2-920-8521 byg@donga.co.kr

Locations
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Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-786
Contact: Kyun-Seop Bae, M.D., Ph.D.    +82-2-3010-4611    ksbae@amc.seoul.kr   
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D.         
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center

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Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01928563     History of Changes
Other Study ID Numbers: DA8159_DIP_I
First Posted: August 26, 2013    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action