A multicentre, randomized, open label, two-period, two-treatment, two-way crossover,bioequivalence study comparing Capecitabine tablets 500 mg with Xeloda®(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic BreastCancer or Colorectal Cancer patients under fed condition. Capecitabine is the test drug(Manufactured by: Jiangsu Hengrui Medicine Co.,China). Xeloda is the reference drug (Distributed by:Roche Registration Limited,UK)
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- To characterise the pharmacokinetic profile of the sponsor’s test formulation
研究概览
简要总结
Capecitabine is a fluoropyrimidine carbamate which is 5’- Deoxy 5 fluoro uridine (5’-DFUR). It is an orally administered prodrug which is converted to 5-fluoro uracil in human body.
This study is being conducted to compare & characterize the relative bioavailability & pharmacokinetic profile of the Sponsor’s formulation (Capecitabine 500mg tab) with respect to the reference formulation ( Xeloda ® (capecitabine 500mg tab)) in single oral dose as multiples of 500 mg tablet in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition.
The primary objective of the study is to characterize the pharmacokinetic profile of the sponsor’s test formulation to that of reference formulation & secondary objective is to monitor the safety of the patients.
Bioequivalence will be concluded if the ln-transformed 90% confidence interval falls within the acceptance range of 80.00 – 125.00% for pharmacokinetic parameters Cmax, AUC of Capecitabine
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m
- •2.Patient with adequate bone marrow, renal and hepatic function.
- •3.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 4.Patients with life expectancy of at least 3 months (as per the Investigator’s discretion) 5.Able to comply with study requirement in opinion of Principal Investigator 6.Able to give written informed consent for participation in the trial 7.Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive).
排除标准
- •1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
- •2.History of drug/alcohol addiction.
- •3.Known brain metastasis 4.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies 5.Known HIV infection.6.History of drug/alcohol addiction.
- •7.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
结局指标
主要结局
To characterise the pharmacokinetic profile of the sponsor’s test formulation
时间窗: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, | 6, 8, 10 hr post-dose in each period administration
[Capecitabine Tablets 500 mg] relative to that of reference formulation [Xeloda® Tablets 500 mg] in patients with
时间窗: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, | 6, 8, 10 hr post-dose in each period administration
Metastatic Breast Cancer or Colorectal Cancer under fed condition and to
时间窗: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, | 6, 8, 10 hr post-dose in each period administration
assess the bioequivalence.
时间窗: The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5, | 6, 8, 10 hr post-dose in each period administration
次要结局
- To monitor safety of the patients, who are exposed to the Investigational(Medicinal Product)