A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetic and Safety After Oral Administration of SVG101(Dispersible Tablet of Everolimus) 5mg and Afinitor 5mg in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Cmax of Everolimus
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.
详细描述
This is a randomized, open-label, single-dose, two-way cross-over study to investigate the Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults: 19y - 55y (Male or Female)
- •Male: more than 55kg, Female: more than 50kg body weight
- •Body mass index: more than 18.5kg/m^2 and less than 27.0kg/m^2
- •Menopause or surgical infertility female
排除标准
- •Participants have or had a history of the clinically relevant disease or abnormalities in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood/tumor, cardiovascular system, and mental illness.
- •Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Any history of gastrointestinal disease or surgery
- •Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product.
- •Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration
- •Receiving any investigational therapy of others within 180 days prior to first administration. In case of biological products, the restricted period can be extended depend on the half-life receipt product
- •Pregnant or breastfeeding women
研究组 & 干预措施
Group I
13 subjects will receive
- First Dose: Afinitor 5mg, single dose
- Wash out period : more than 10 days
- Second Dose: SVG101 5mg, single dose
干预措施: SVG101 (T) (Drug)
Group I
13 subjects will receive
- First Dose: Afinitor 5mg, single dose
- Wash out period : more than 10 days
- Second Dose: SVG101 5mg, single dose
干预措施: Afinitor (R) (Drug)
Group II
13 subjects will receive
- First Dose: SVG101 5mg, single dose
- Wash out period : more than 10 days
- Second Dose: Afinitor 5mg, single dose
干预措施: SVG101 (T) (Drug)
Group II
13 subjects will receive
- First Dose: SVG101 5mg, single dose
- Wash out period : more than 10 days
- Second Dose: Afinitor 5mg, single dose
干预措施: Afinitor (R) (Drug)
结局指标
主要结局
Cmax of Everolimus
时间窗: up to 144 hours
AUCinf of everolimus
时间窗: up to 144 hours
Cmin,ss,pred of Everolimus
时间窗: up to 144 hours
AUClast of Everolimus
时间窗: up to 144 hours
Clearance of Everolimus
时间窗: up to 144 hours
t1/2 of Everolimus
时间窗: up to 144 hours
Tmax of Everolimus
时间窗: up to 144 hours
Vd/F of Everolimus
时间窗: up to 144 hours
次要结局
- Adverse Events (AEs)(up to approximately 45 days)