CTRI/2016/06/007043已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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
- •- Pre-existing clinically significant peripheral neuropathy
- •- Inability to undergo venipuncture and/or tolerate venous access
- •- Known hypersensitivity to either of the study drugs or their excipients
研究者
相似试验
已完成
不适用
Pharmacokinetic study of SPARC1613 and Reference1613CTRI/2016/12/007565Sun Pharma Advanced Research Company Limited142
Unknown
1 期
A Randomized, Open Label,Two Period, Single Dose Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Patients with Breast CancerCTRI/2014/04/004528Sun Pharma Advanced Research Company Ltd72
Unknown
1 期
Bioavailability Study of Paclitaxel Injection Concentrate for Suspension in Subjects with Locally Recurrent or Metastatic Breast Cancer.CTRI/2020/03/024065Sun Pharma Advanced Research Company Limited
已完成
不适用
Randomized, Open Label, Single-Dose, Two Period, Two Treatment, Two Sequence, Cross-over, Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety of Rabeprazole Sodium Delayed-release Capsule 20 mg in Healthy Volunteers.CTRI/2017/07/008985Cadila Healthcare Limited12
尚未招募
1 期
A Single Dose, Randomized, Open-label, Two-period, Two-sequence Crossover Bioequivalence Study of Generic Linagliptin/Metformin Hydrochloride Tablets 2.5 mg/1000 mg and Reference Product (TRAJENTA DUO) in Healthy Thai Volunteers under Fed ConditionsBioequivalence Study Healthy Thai VolunteersTCTR20231012008International Bio Service Co., Ltd.40
