KCT0000734已完成未知
A randomized, open, single dose, 2-way crossover study in healthy male volunteers to evaluate the safety and the pharmacokinetics of Please orally soluble film 50 mg (Sildenafil) without water relative to VIAGRA® 50 mg (Sildenafil citrate) with water
CTC Bio0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1. Healthy male subjects between the ages of 20 and 55 years
- •2. Ideal Body Weight(IBW) of +-20%; and a total body weight >= 50 kg
- •3. An informed consent document signed and dated by the subject.
排除标准
- •1. Evidence or a history of clinically significant hepatic, pancreas, renal, neurological, pulmonary, endocrine, hematological, psychiatric, cardiovascular, eye, genitourinary disease
- •2. Any disease or history possibly affecting drug absorption (e.g. chohn's disease, gastrectomy).
- •3. Any condition possibly affecting drug absorption (stomatitis, glottitis)
- •4. sildenafil-associated allergy history
- •5. systolic blood pressure (SBP) = 150 mmHg or =100 mmHg or diastolic blood pressure (DBP) = 95 mmHg or = 65 mmHg
- •6. received any prescription medication or herbal medicines within 3 weeks or any over-the-counter medication within 10 days before the study
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