Drug Interaction Potentiation
Conditions
Keywords
Dapoxetine, Mirodenafil, DDI study
Brief 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.
Interventions
DRUGDapoxetine 30mg tablet
DRUGMirodenafil 50mg tablet
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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 * eGFR \< lower limit of normal range * Subject considered as unsuitable based on medical judgement by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Tmax | 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 | During 22 days from first administration of period 1 | Incidence rate of Adverse events |
| 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 | — |
| 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 | — |
Outcome results
None listed