A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet in Healthy Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers
详细描述
This is a randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
- •A Healthy female volunteers, aged 19-45 years
- •BMI 18 ~ 27(kg/m2)
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •History of gastrointestinal disease and resection
- •History of clinically significant hypersensitivity to study drug, any other drug
- •A subject with clinically significant genital bleeding
- •Participation in any other study within 3 months
- •Positive results for urine β-hCG in screening or lactating women
- •A subject is using a method of hormone contraception and a Progesterone intrauterine device
研究组 & 干预措施
BR-UPS 5 mg tablet
干预措施: BR-UPS 5 mg tablet, Inisia 5 mg tablet (Drug)
Inisia 5 mg tablet
干预措施: BR-UPS 5 mg tablet, Inisia 5 mg tablet (Drug)
结局指标
主要结局
Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
时间窗: 0~120 hours after medication
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate
时间窗: 0~120 hours after medication
次要结局
未报告次要终点