An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- AUC from time 0 extrapolated to time infinity (AUC 0-∞)
研究概览
简要总结
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
详细描述
This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects aged 40 to 65 years old, inclusive, at Screening
- •Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m^2 inclusive)
- •Laboratory tests within the normal range
- •Serum 25-hydroxyvitamin D values must be > 20 ng/mL
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
- •History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
- •History of allergy to abaloparatide or drugs in a similar pharmacological class;
结局指标
主要结局
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
时间窗: 4 single-dose administrations, separated by 48 hours.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
时间窗: 4 single-dose administrations, separated by 48 hours.
Maximum observed concentration (Cmax)
时间窗: 4 single-dose administrations, separated by 48 hours.
次要结局
- Subjects with treatment-emergent AEs and SAEs(14 ± 2 days)