NCT00863174已完成1 期
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
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
- 24
- 主要终点
- 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
研究概览
简要总结
Safety and bioequivalence of SPARC_147709
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability for the entire study period and willingness to adhere to protocol requirements.
- •Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
- •18 years of age or older
- •No evidence of underlying disease (except multiple myeloma)
排除标准
- •History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
- •History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
- •History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
- •Positive result to HIV, HCV, RPR and HBsAg.
研究组 & 干预措施
1
Experimental
SPARC147709
干预措施: SPARC147709 (Drug)
2
Active Comparator
Reference147709
干预措施: Reference147709 (Drug)
结局指标
主要结局
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
时间窗: 2 cycles
次要结局
- Treatment Emergent Adverse Events(2 cycles)
研究者
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