Drug Interaction PotentiationPhase 1NCT02485028
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg
A Phase 1 study testing Dapoxetine 30mg tablet and Mirodenafil 50mg tablet in people with Drug Interaction Potentiation, run by SK Chemicals Co., Ltd..
Trial summary
Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction Potentiation
- What is being tested?
- Dapoxetine 30mg tablet and Mirodenafil 50mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged between 19 and 55
- Body mass index (BMI) in the range of 19 to 27 kg/m2
- Understand the requirements of the study and voluntarily consent to participate in the study
- Available for the entire study period
Who cannot join
- Subject has a history such as liver diseases, kidneys, digestive system, respiratory system, endocrine system, nervous psychiatric, blood, cancer, cardiovascular diseases
- Subject with clinically significant vital signs (sitting position blood pressure) (90 mmHg > systolic blood pressure ≥ 140 mmHg, 60 mmHg > diastolic blood pressure ≥ 90 mmHg)
- History of drug abuse
- History of caffeine, alcohol, smoking abuse
- caffeine(coffee,tea,coke)> 4cups/day
- smoking > 10 cigarettes/day
Show all 15Show fewer
- alcohol > 140g/week
- Consumption of any grapefruit or grapefruit-containing juices over 1 cup a day
- Previously donate whole blood within 60 days or component blood within 30 days
- Subject has taken drugs which affects the ADME of investigational products
- Subject with known for hypersensitivity reactions to mirodenafil/ dapoxetine or other drugs
- Inadequate laboratory test result:
- AST(SGOT) or ALT(SGPT) or total bilirubin > 1.5 x upper limit of normal range
- eGFR < lower limit of normal range
- Subject considered as unsuitable based on medical judgement by investigators
About this study
Official title: An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers
Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.
- Conditions
- Drug Interaction Potentiation
- Being tested
- Dapoxetine 30mg tablet, Mirodenafil 50mg tablet
- Keywords
- Dapoxetine, Mirodenafil, DDI study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapoxetine 30mg tabletDrug
Mirodenafil 50mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| M→D→D+M | Experimental | Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 Receives: Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet |
| M→D+M→D | Experimental | Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3 Receives: Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet |
| D→M→D+M | Experimental | Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 Receives: Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet |
| D+M→M→D | Experimental | Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3 Receives: Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet |
| D+M→D→M | Experimental | Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3 Receives: Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet |
| D→D+M→M | Experimental | Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3 Receives: Drug: Dapoxetine 30mg tablet; Drug: Mirodenafil 50mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax of dapoxetine and mirodenafil
Measured: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Area Under Curve (AUC)
AUC of dapoxetine and mirodenafil
Measured: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Secondary outcomes (5)
Tmax
Measured: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
t1/2
Measured: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
CL/F
Measured: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Vd/F
Measured: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Number of Participants with Adverse Events
Incidence rate of Adverse events
Measured: During 22 days from first administration of period 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Interaction PotentiationStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Wook Ko, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485028
- Sponsor's protocol ID
- SID123_DDI_I_2013
- Other IDs
- 12542
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02485028
- Acronym / sponsor ID
- SID123_DDI_I_2013
- Conditions
- Drug Interaction Potentiation
- Keywords
- Dapoxetine, Mirodenafil, DDI study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Jun 2015 (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.
Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| M→D→D+M | Experimental | Drug: Dapoxetine 30mg tablet, Drug: Mirodenafil 50mg tabletMirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 |
| M→D+M→D | Experimental | Drug: Dapoxetine 30mg tablet, Drug: Mirodenafil 50mg tabletMirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3 |
| D→M→D+M | Experimental | Drug: Dapoxetine 30mg tablet, Drug: Mirodenafil 50mg tabletDapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 |
| D+M→M→D | Experimental | Drug: Dapoxetine 30mg tablet, Drug: Mirodenafil 50mg tabletDapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3 |
| D+M→D→M | Experimental | Drug: Dapoxetine 30mg tablet, Drug: Mirodenafil 50mg tabletDapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3 |
| D→D+M→M | Experimental | Drug: Dapoxetine 30mg tablet, Drug: Mirodenafil 50mg tabletDapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adults aged between 19 and 55
- Body mass index (BMI) in the range of 19 to 27 kg/m2
- Understand the requirements of the study and voluntarily consent to participate in the study
- Available for the entire study period
Key exclusion criteria (15 listed)
- Subject has a history such as liver diseases, kidneys, digestive system, respiratory system, endocrine system, nervous psychiatric, blood, cancer, cardiovascular diseases
- Subject with clinically significant vital signs (sitting position blood pressure) (90 mmHg > systolic blood pressure ≥ 140 mmHg, 60 mmHg > diastolic blood pressure ≥ 90 mmHg)
- History of drug abuse
- History of caffeine, alcohol, smoking abuse
- Consumption of any grapefruit or grapefruit-containing juices over 1 cup a day
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 |
|---|---|---|
| Dapoxetine 30mg tablet | Drug | D+M→D→M, D+M→M→D, D→D+M→M, D→M→D+M, M→D+M→D, M→D→D+M |
| Mirodenafil 50mg tablet | Drug | D+M→D→M, D+M→M→D, D→D+M→M, D→M→D+M, M→D+M→D, M→D→D+M |
Primary outcome
Cmax
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Cmax of dapoxetine and mirodenafil
Area Under Curve (AUC)
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
AUC of dapoxetine and mirodenafil
5 secondary outcomes
Tmax
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
t1/2
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
CL/F
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Vd/F
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Number of Participants with Adverse Events
Time frame: During 22 days from first administration of period 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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.
Jae-Wook Ko, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapoxetine 30mg tablet and Mirodenafil 50mg tablet in people with Drug Interaction Potentiation, run by SK Chemicals Co., Ltd..
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose). The study lists 2 primary outcomes in all. 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 30 Jun 2015.