A Multicentre, Randomized, Open Label, Two-Period, Two-Treatment,Two-Way Crossover, Comparative Bioavailability Study At Steady StateComparing Capecitabine Extended Release Capsule 500 mg (IntasPharmaceuticals Ltd., India) To The Reference Listed Drug Xeloda®(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of BreastCancer Or Colorectal Cancer Under Fed Condition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- AUC
研究概览
简要总结
The Sponsor has developed extended release formulation of capecitabine.Capecitabine is a cytotoxic drug. It would be unethical to do this study inhealthy volunteers. Therefore the comparative bioavailability study is proposedto be carried out on patients with Breast Cancer or Colorectal cancer, who inthe opinion of their treating physicians are candidates for Capecitabinetherapy
In current study, test formulation of capecitabine ER capsule 500 mgwill be administered as twice daily for one week and reference formulation of capecitabine- Xeloda® (capecitabine) tablets 500 mg will be administered twice daily forone week in a crossover manner in patients with breast cancer or colorectalcancer under fed condition. Through this study, we will prospectively collectthe data from adult breast cancer or colorectal cancer patients who will berandomly assigned to receive either capecitabine extended release capsule ofIntas Pharmaceuticals Limited, India or Xeloda®
(Capecitabine500 mg; Roche Pharmaceuticals) for the pharmacokinetic profiling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female ≥18 to ≤ 65 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2
- •Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer.
- •3.Patients with a.
- •Metastatic colorectal carcinoma when treatment with fluoro pyrimidine therapy alone is preferred.
- •Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patient with adequate bone marrow, renal and hepatic function.
- •Adequate Cardiac function (left ventricular ejection fraction[LVEF] ≥50%)
- •Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
- •Able to comply with study requirement in opinion of Principal Investigator.
- •Able to give written informed consent for participation in the trial.
排除标准
- •1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
- •Pregnant or breast-feeding female
- •Known brain metastasis
- •Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI CTCAE criteria.
- •A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies
- •Known case of HIV infection.
- •Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
结局指标
主要结局
AUC
时间窗: Day 07 and Day 14
次要结局
- To monitor the safety of the patients who are exposed to the investigational medicinal product.(Day 1 to Day 14)