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| ID | Type | Description | Link |
|---|---|---|---|
| 12542 | Other Identifier | South Korea: Ministry of Food and Drug Safety |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M→D→D+M | Experimental | Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 |
|
| M→D+M→D | Experimental | Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3 |
|
| D→M→D+M | Experimental | Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 |
|
| D+M→M→D | Experimental | Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3 |
|
| D+M→D→M | Experimental | Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapoxetine 30mg tablet | Drug |
| ||
| 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 |
| 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 | |
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Inclusion Criteria:
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
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:
Subject considered as unsuitable based on medical judgement by investigators
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Wook Ko, MD, PhD | Samsung Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| C080598 | dapoxetine |
| D013607 | Tablets |
| C528396 | mirodenafil |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| D→D+M→M | Experimental | Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3 |
|
| Mirodenafil 50mg tablet |
| Drug |
|
| 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 |