NCT03055143已完成1 期
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Maximum measured plasma concentration
研究概览
简要总结
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
- •Subjects who had no evidence of underlying disease
- •Subjects who had signed written consent form
排除标准
- •Females who were pregnant, breastfeeding, or are likely to become pregnant
- •Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
- •Subjects deemed uncooperative or noncompliant
- •Smoking or consumption of any nicotine products
研究组 & 干预措施
SPARC-08-038
Experimental
2 mg/ml
干预措施: SPARC-08-038 (Drug)
SPARC-08-038
Experimental
2 mg/ml
干预措施: Ref-08-038 (Drug)
Ref-08-038
Active Comparator
干预措施: SPARC-08-038 (Drug)
Ref-08-038
Active Comparator
干预措施: Ref-08-038 (Drug)
结局指标
主要结局
Maximum measured plasma concentration
时间窗: 336 hours
次要结局
- The area under the plasma concentration versus time curve from time 0 to infinity(336 hours)
研究者
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