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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01928563

Enrollment

Registered

2013-08-26

Start date

2013-09-30

Completion date

2013-12-31

Last updated

2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

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

Interventions

DRUGDapoxetine

DRUGUdenafil

DRUGUdenafil+Dapoxetine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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)

Design outcomes

Primary

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

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)

Countries

South Korea

Contacts

Primary ContactYong-Goo Bae, MSc

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026