A Bio Equivalence Study of DOXIL and Doxorubicin in Subjects With Lymphoma, Leukemia and Carcinoma
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Bioavailability of Doxil versus Doxorubicin
研究概览
简要总结
Doxil or Doxorubicin to be administered was administered in a dose of 50 mg/m2 as infusion over 15 minutes. Blood samples to be obtained at 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours
详细描述
Comparison of AUC in a single dose of Doxorubicin vs single dose of Doxil [ Time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days) The primary objective of this study is to determine the pharmacokinetic equivalence of Doxorubicin and Doxil as a single dose in patients with carcinomas, lymphomas and leukemia's. The outcome measure will be determined by analyzing the concentration from each patient at pre-specified time points and calculating Area under the curve (AUC) and Peak Plasma Concentration (C max)to determine % variability between doxorubicin and Doxil within each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria
- •Inclusion Criteria:
- •Have confirmed diagnosis of lymphomas. leukemia's and carcinoma to be treated with Doxil or Doxorubin Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
- •Be >/= 18 and </= 75 years of age Sign a written Institutional Review Board (IRB)-approved informed consent form Have a negative pregnancy test, if patient is of child-bearing potential. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential) Have acceptable liver function, renal function and hematologic status based on the institution.
- •Exclusion criteria Any Medical related exclusion criteria as per the institution. Are unwilling or unable to comply with procedures required in this protocol Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor Are currently receiving any other investigational agent Have exhibited allergic reactions to doxorubicin or a similar structural compound
排除标准
- 未提供
研究组 & 干预措施
Doxil
This group of patients will receive Intravenous Doxil of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days
干预措施: Doxorubicin (Drug)
doxorubicin
This group of patients will receive Intravenous Doxorubicin of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Bioavailability of Doxil versus Doxorubicin
时间窗: 72 hours . Cycle defined as 28 days
Intravenous Doxil versus Doxorubicin of 50mgm/m2 over 15 minutes and plasma concentration will be measured at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days. Maximum observed plasma concentration of doxorubicin versus Doxil in participants at time Frame: 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours. Cycle is defined as 28 days.
次要结局
未报告次要终点
研究者
Dr. Ajai Prakash
President
Sutphin Drugs