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Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

NCT01928563•Dong-A Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

20 - 45 years

Sex

MALE

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)

Locations (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Key Dates

Start Date

September 1, 2013

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

August 26, 2013

Enrollment

ESTIMATED participants

Conditions

Healthy Male Subjects

Interventions

Dapoxetine

DRUG

Udenafil

DRUG

Udenafil+Dapoxetine

DRUG

Contacts

Yong-Goo Bae, MSc

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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