CTRI/2012/07/002778已完成不适用
A multicentre, randomized, open label, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study comparing Capecitabine Tablets 500 mg (Manufactured by: Hetero Labs Ltd, India) and the reference listed drug Xeloda® (Capecitabine) 500 mg film coated tablets (Manufactured by Roche Pharma AG, Emil-Barell – Str I, D-79639 Grenzach-Wyhlen, Duitsland) in locally advanced or Metastatic Breast Cancer or colorectal Cancer or advanced gastric cancer adult subjects already receiving a stable twice-daily dosing regimen as prescribed by the reference product label under fed condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Establishing the bioequivalence between test and reference
研究概览
简要总结
This is an open-label, randomized, single dose, and two treatment periods, two sequence cross-over study in locally advanced breast cancer or metastatic breast cancer or colo rectal cancer or advanced gastric cancer.
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.Established cases of advanced breast cancer or metastatic breast cancer or colo-rectal cancer or advanced gastric cancer (in combination with a platinum based regimen), who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet.
- •2.Life expectancy of at least 3 months 3.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
排除标准
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
- •Positive alcohol or drug abuse test at baseline.
- •Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively.
- •Have received any live or live attenuated vaccines within 2 months prior to randomization.
结局指标
主要结局
Establishing the bioequivalence between test and reference
时间窗: Day 1 and Day 2
次要结局
- AUClast AUCinf Cmax λz Tmax and T1/2 and other parameters as appropriate from plasma concentration time(Day 1 and Day 2)
研究者
研究点 (6)
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