Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg

Study Overview
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Brief Summary
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Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.

Detailed Description
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Healthy male volunteers were randomized into one group among 6 sequential groups and were administered alone or in combination with dapoxetine 30mg mirodenafil 100mg in each period. Bloods were obtained at each time for pharmacokinetic analysis. Safety evaluation was also done during entire study period.

Official Title
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An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30 mg and Mirodenafil 100 mg in Healthy Male Volunteers

Conditions
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Drug Interaction Potentiation

Intervention / Treatment
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* Drug: Dapoxetine 30mg
* Drug: Mirodenafil 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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 Subject considered as unsuitable based on medical judgement by investigators

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M→D→D+M<br>Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 | Drug: Dapoxetine 30mg<br>* Tablet, Orally administered<br>Drug: Mirodenafil 100mg<br>* Table, Orally administered<br>|
| Experimental: M→D+M→D<br>Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3 | Drug: Dapoxetine 30mg<br>* Tablet, Orally administered<br>Drug: Mirodenafil 100mg<br>* Table, Orally administered<br>|
| Experimental: D→M→D+M<br>Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 | Drug: Dapoxetine 30mg<br>* Tablet, Orally administered<br>Drug: Mirodenafil 100mg<br>* Table, Orally administered<br>|
| Experimental: D→D+M→M<br>Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3 | Drug: Dapoxetine 30mg<br>* Tablet, Orally administered<br>Drug: Mirodenafil 100mg<br>* Table, Orally administered<br>|
| Experimental: D+M→M→D<br>Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3 | Drug: Dapoxetine 30mg<br>* Tablet, Orally administered<br>Drug: Mirodenafil 100mg<br>* Table, Orally administered<br>|
| Experimental: D+M→D→M<br>Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3 | Drug: Dapoxetine 30mg<br>* Tablet, Orally administered<br>Drug: Mirodenafil 100mg<br>* Table, Orally administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Cmax of dapoxetine and mirodenafil | 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 | predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 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 |  | 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 |  | 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 |  | 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 | During 22 days from first administration of period 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapoxetine, Mirodenafil, DDI study