Relative Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations In Healthy Volunteers Under Fasting Conditions.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC0-T and Cmax of sildenafil
研究概览
简要总结
the pharmacokinetics of sildenafil following single doses of sildenafil CT administered with and without water is similar relative to the conventional oral tablet of sildenafil administered with water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Only healthy male volunteers in the 18-40 age range will be included.
- •At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90
- •The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication
- •History of hypersensitivity to sildenafil citrate or any components of its formulations
研究组 & 干预措施
Treatment C
Sildenafil 100 mg CT administered without water
干预措施: Blood samples for the analysis of sildenafil in plasma (Other)
Treatment A
Viagra® 100 mg tablet, administered with water
干预措施: Treatment A (Drug)
Treatment A
Viagra® 100 mg tablet, administered with water
干预措施: Blood samples for the analysis of sildenafil in plasma (Other)
Treatment B
Sildenafil 100 mg CT administered with water
干预措施: Treatment B (Drug)
Treatment B
Sildenafil 100 mg CT administered with water
干预措施: Blood samples for the analysis of sildenafil in plasma (Other)
Treatment C
Sildenafil 100 mg CT administered without water
干预措施: Treatment C (Drug)
结局指标
主要结局
AUC0-T and Cmax of sildenafil
时间窗: 28 days
次要结局
- AUC0-inf of sildenafil(28 days)
- Tmax and half-life of sildenafil(28 days)
- Adverse events and vital signs(28 days)