An Open, Randomized, Two-way Cross-over Phase I Study to Compare the Bioavailability, Safety and Tolerability of Single s.c. Doses of 300 IU XM17 With 300 IU Gonal-f® in 36 Healthy, Down-regulated Young Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Merckle GmbH
- 入组人数
- 49
- 主要终点
- Comparison of single dose pharmacokinetics (Cmax)
研究概览
简要总结
Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.
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
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having signed written informed consent
- •Healthy female subjects of any racial origin
- •18-39 years at the time of screening
- •Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg
- •Use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months
- •Normal uterus and two functioning ovaries
- •Agrees to use an adequate method of contraception during the study
- •Non-smoking or moderate smokers of < 10 cigarettes a day
排除标准
- •Pregnancy
- •Polycystic ovary syndrome, impaired ovarian function, severe endometriosis class III or IV, submucosal myoma uteri
- •History of endocrine abnormalities with treatment within the last six months.
- •Contraindications for the use of gonadotropins and goserelin
- •Breast-feeding or being within a period of 2 months after delivery or abortion.
- •Use of an injectable hormonal contraceptive within a period of 6 months prior to screening
- •Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ
研究组 & 干预措施
XM17
XM17 will be administered by 1 mL syringes in graduated steps of 0.01 mL.
干预措施: XM17 (Drug)
Gonal-f®
Gonal-f® will be provided in pens with integrated vials of 0.5 mL
干预措施: Gonal-f® (Drug)
Zoladex®
Zoladex® 3.6 mg will be administered by subcutaneous injection
干预措施: Zoladex® (Drug)
结局指标
主要结局
Comparison of single dose pharmacokinetics (Cmax)
时间窗: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
XM17 and Gonal-f® tested statistically for bioequivalence.
Comparison of single dose pharmacokinetics (AUC0-t)
时间窗: Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
XM17 and Gonal-f® tested statistically for bioequivalence.
次要结局
- Pharmacokinetics AUC0-168h(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics AUC0-∞(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics λZ(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics Cmax,obs(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics Tmax(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics t1/2(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics CL/F(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Pharmacokinetics Vz/F(Pre-dose at -10 min, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose)
- Percentage of participants with adverse events(Signing of informed consent to final data collection (27 days))