CTRI/2016/06/007043已完成不适用
A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of SPARC1612 and reference1612 in Subjects with Locally Recurrent or Metastatic Breast Cancer (MBC).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 18
- 主要终点
- Pharmacokinetic parameter: Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
This clinical study is designed to characterize PK parameters and potential BE for PICN and Abraxane and to evaluate safety of both formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study.
- •Histologically or cytologically confirmed diagnosis of breast cancer.
- •Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option.
- •Male or female aged ≥ 18 years.
排除标准
- •Presence of clinically symptomatic active CNS metastases.
- •Inability to undergo venipuncture and/or tolerate venous access.
- •Known hypersensitivity to either of the study drugs or their excipients.
结局指标
主要结局
Pharmacokinetic parameter: Cmax, AUC0-t and AUC0-∞
时间窗: up to 72 hours
次要结局
- Adverse events(51 days)
研究者
研究点 (18)
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