Healthy Male SubjectsPhase 1NCT01928563
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine
A Phase 1 study testing Dapoxetine, Udenafil and Udenafil+Dapoxetine in people with Healthy Male Subjects, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- Dapoxetine, Udenafil and Udenafil+Dapoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center
Seoul, Songpa-gu, 138-786
Kyun-Seop Bae, M.D., Ph.D., +82-2-3010-4611, ksbae@amc.seoul.kr
Kyun-Seop Bae, M.D., Ph.D.
About this study
Official title: 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
- Conditions
- Healthy Male Subjects
- Being tested
- Dapoxetine, Udenafil, Udenafil+Dapoxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapoxetineDrug
Also called Brand name : Priligy, Dapoxetine is administered
UdenafilDrug
Also called Brand name : Zydena, Code name : DA-8159, Udenafil is administered
Udenafil+DapoxetineDrug
Also called Udenafil and Dapoxetine are co-adminstered
| Study group | Role | What they receive |
|---|---|---|
| Dapoxetine | Experimental | Dapoxetine is administered Receives: Drug: Dapoxetine |
| Udenafil | Experimental | Udenafil is administered Receives: Drug: Udenafil |
| Udenafil and Dapoxetine | Experimental | Udenafil and Dapoxetine are co-administered Receives: Drug: Udenafil+Dapoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUClast of Udenafil and Dapoxetine
Measured: 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)
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h (each period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928563
- Sponsor's protocol ID
- DA8159_DIP_I
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01928563
- Acronym / sponsor ID
- DA8159_DIP_I
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapoxetine | Experimental | Drug: DapoxetineDapoxetine is administered |
| Udenafil | Experimental | Drug: UdenafilUdenafil is administered |
| Udenafil and Dapoxetine | Experimental | Drug: Udenafil+DapoxetineUdenafil and Dapoxetine are co-administered |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapoxetineAlso: Brand name : Priligy, Dapoxetine is administered | Drug | Dapoxetine |
| UdenafilAlso: Brand name : Zydena, Code name : DA-8159, Udenafil is administered | Drug | Udenafil |
| Udenafil+DapoxetineAlso: Udenafil and Dapoxetine are co-adminstered | Drug | Udenafil and Dapoxetine |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyun-Seop Bae, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapoxetine, Udenafil and Udenafil+Dapoxetine in people with Healthy Male Subjects, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-Goo Bae, MSc (+82-2-920-8521, byg@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.