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

NCT01928563 | Unknown Phase 1

• 1 other identifier: DA8159_DIP_I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (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 Outcomes (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)

Study Arms (3)

Dapoxetine

EXPERIMENTAL

Dapoxetine is administered

Drug: Dapoxetine

Udenafil

EXPERIMENTAL

Udenafil is administered

Drug: Udenafil

Udenafil and Dapoxetine

EXPERIMENTAL

Udenafil and Dapoxetine are co-administered

Drug: Udenafil+Dapoxetine

Interventions

Dapoxetine DRUG

Also known as: Brand name : Priligy, Dapoxetine is administered

Dapoxetine

Udenafil DRUG

Also known as: Brand name : Zydena, Code name : DA-8159, Udenafil is administered

Udenafil

Udenafil+Dapoxetine DRUG

Also known as: Udenafil and Dapoxetine are co-adminstered

Udenafil and Dapoxetine

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-786, South Korea

Location

MeSH Terms

Interventions

dapoxetine; udenafil

Study Officials

• Kyun-Seop Bae, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Goo Bae, MSc

CONTACT

+82-2-920-8521; byg@donga.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 26, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

KR (1)