Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg
- Conditions
- Drug Interaction Potentiation
- Interventions
- Registration Number
- NCT02485028
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description D→D+M→M Mirodenafil 50mg tablet Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3 M→D→D+M Dapoxetine 30mg tablet Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 M→D→D+M Mirodenafil 50mg tablet Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 M→D+M→D Dapoxetine 30mg tablet Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3 M→D+M→D Mirodenafil 50mg tablet Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3 D→M→D+M Dapoxetine 30mg tablet Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 D→M→D+M Mirodenafil 50mg tablet Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3 D+M→M→D Dapoxetine 30mg tablet Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3 D+M→M→D Mirodenafil 50mg tablet Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3 D+M→D→M Dapoxetine 30mg tablet Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3 D+M→D→M Mirodenafil 50mg tablet Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3 D→D+M→M Dapoxetine 30mg tablet Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 During 22 days from first administration of period 1 Incidence rate of Adverse events