Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Drug-induced changes of hand vein compliance
研究概览
简要总结
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.
详细描述
In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, male individuals, age: 18-
- •Able and willing to give written informed consent
排除标准
- •Hypotension ( 65 mmHg diastolic and 100 mmHg systolic blood pressure)
- •Bleeding disorders in medical history
- •Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks
- •Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking)
- •Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie's disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia)
- •Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case)
- •alcohol (>30 g/d) or drug abuse
- •Acute or chronic illness
- •Blood donation within the preceding 2 months
- •Participation in clinical trial within 2 month before the study
- •Drug and/or alcohol abuse.
结局指标
主要结局
Drug-induced changes of hand vein compliance
Drug-induced changes of pharmacokinetic parameters
次要结局
未报告次要终点