NCT00862355已完成1 期
Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer
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
- 试验地点
- 1
- 主要终点
- 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product
研究概览
简要总结
Bioequivalence study of SPARC147609
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all of the following criteria will be considered for enrollment in the study:
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements.
- •Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
- •Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
- •Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
- •Informed consent form given in written form.
排除标准
- •History or presence of significant:
- •Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
- •Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- •Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg.
- •Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
- •Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
- •Participation in another clinical trial within the preceding 90 days of study start
- •Subjects who have:
- •Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- •Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
- •Pulse rate below 60/min. or above 100/min
研究组 & 干预措施
1
Experimental
SPARC147609
干预措施: SPARC147609 (Drug)
2
Active Comparator
Reference147609
干预措施: Reference147609 (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 product
时间窗: 2 cycles
次要结局
- Treatment emergent adverse events(2 cycles)
研究者
研究点 (1)
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