A multicentre, randomized, open-label, single dose, two-treatment, three-period, three-sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 13
- 主要终点
- To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours:
研究概览
简要总结
The purpose of the study is to demonstrate the bioequivalence between Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, GermanyThe patients will either be assigned to Test or Reference product. The bioequivalence will be assessed under fed conditions. In each period, all patients will observe overnight fasting of at least 10 hours prior to intake of a high calorie high fat breakfast. As per the randomization schedule, the patients will be administered a single dose of either Test capecitabine or Reference Xeloda® within 30 minutes after intake of a high calorie high fat breakfast. Patients will be instructed not to chew or crush the drug, and will be asked to take it with the specified quantity of water. Compliance will be assessed by conducting a thorough examination of the oral cavity using a flashlight and spatula by trained study personnel after each dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or females 18 to 65 years of age.
- •2.Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m
- •3.Patients in whom capecitabine is indicated as adjuvant treatment following surgery of stage III (Dukes’ stage C) colon cancer Or Patients with metastatic colorectal cancer Or Patients with locally-advanced or metastatic breast cancer 4.Cancer patients who are already receiving stable twice-daily dosing regimen of capecitabine as monotherapy as prescribed by treating physician.
- •5.Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •6.Patients with life expectancy of at least 3 months.
- •7.Patients should be non-smokers.
- •8.Patients willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.
排除标准
- •Exclusion Criteria 1.Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
- •2.Pregnant (female patients with a positive serum pregnancy test at screening or positive urine pregnancy test before period I of hospitalization) or lactating females 3.Patients with the following abnormal laboratory parameters: 4.Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil, receiving concomitant therapy of warfarin,or known Dihydropyrimidine dehydrogenase (DPD) deficiency.
- •5.Patients with known brain metastasis 6.History or evidence of uncontrolled coagulopathy.
- •7.History of hereditary galactose/ glucose/ lactase disorders.
- •8.History or evidence of cardiac disease 9.Patients with a history of alcoholism, or drug abuse 10.Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- •11.Patients having an abnormal serum calcium level 12.Patients who have participated in any other clinical investigation using experimental drugs 13.Patients with hepatic impairment and severe renal impairment.
结局指标
主要结局
To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours:
时间窗: To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours: | • Cmax | • AUC0-t
• Cmax
时间窗: To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours: | • Cmax | • AUC0-t
• AUC0-t
时间窗: To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters of Capecitabine during the course of study. PK sampling from Day1 to Day3. 12 PK samples in each period from 0 hours to 8 hours: | • Cmax | • AUC0-t
次要结局
- 1. To monitor adverse events, including clinically significant laboratory parameters.(2. To determine other pharmacokinetic parameters of Test and Reference products for Capecitabine during the course of study)