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

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine in Healthy Male Subjects

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

Study Overview

• Status: Unknown
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: Dapoxetine; Drug: Udenafil; Drug: Udenafil+Dapoxetine

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yong-Goo Bae, MSc; Phone Number: +82-2-920-8521; Email: byg@donga.co.kr

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-786
      • Asan Medical Center
      • Contact: Kyun-Seop Bae, M.D., Ph.D.; Phone Number: +82-2-3010-4611; Email: ksbae@amc.seoul.kr
      • Principal Investigator: Kyun-Seop Bae, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Dong-A Pharmaceutical Co., Ltd.
• Collaborators: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 26, 2013

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 21, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: DA8159_DIP_I