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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
M→D+M→D
Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3
干预措施: Mirodenafil 100mg (Drug)
M→D→D+M
Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3
干预措施: Dapoxetine 30mg (Drug)
M→D→D+M
Mirodenafil(M) in period 1, Dapoxetine(D) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3
干预措施: Mirodenafil 100mg (Drug)
M→D+M→D
Mirodenafil(M) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Dapoxetine(D) in period 3
干预措施: Dapoxetine 30mg (Drug)
D→M→D+M
Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3
干预措施: Dapoxetine 30mg (Drug)
D→M→D+M
Dapoxetine(D) in period 1, Mirodenafil(M) in period 2, Dapoxetine+Mirodenafil(D+M) in period 3
干预措施: Mirodenafil 100mg (Drug)
D→D+M→M
Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3
干预措施: Dapoxetine 30mg (Drug)
D→D+M→M
Dapoxetine(D) in period 1, Dapoxetine+Mirodenafil(D+M) in period 2, Mirodenafil(M) in period 3
干预措施: Mirodenafil 100mg (Drug)
D+M→M→D
Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3
干预措施: Dapoxetine 30mg (Drug)
D+M→M→D
Dapoxetine+Mirodenafil(D+M) in period 1, Mirodenafil(M) in period 2, Dapoxetine(D) in period 3
干预措施: Mirodenafil 100mg (Drug)
D+M→D→M
Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3
干预措施: Dapoxetine 30mg (Drug)
D+M→D→M
Dapoxetine+Mirodenafil(D+M) in period 1, Dapoxetine(D) in period 2, Mirodenafil(M) in period 3
干预措施: Mirodenafil 100mg (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: 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
Cmax
时间窗: 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
次要结局
- 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)
- 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)