NCT01493336已完成1 期
A Randomized, Open-label, Single Dose, Two-way Cross-Over Study to Investigate the Relative Bioavailability of Capecitabine in Rapid Disintegrating Tablets (RDT) Versus the Commercial Xeloda® Tablets Following Oral Administrations in Adult Patients With Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Relative bioavailability: Area under the concentration-time curve (AUC)
研究概览
简要总结
This randomized, open-label, two-way crossover study will evaluate the relative bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2 of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients,>/= 18 years of age
- •Histological/cytological confirmation of colorectal or breast cancer
- •Patient is ambulatory and has a Karnofsky performance status of > 70%
- •Body surface area between 1.5 and 2.0 m2
- •Due to receive Xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
- •Currently receiving Xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on Day 1 and Day 2
排除标准
- •Any contraindication to Xeloda
- •Received Xeloda in the 6 days prior to Day 1
- •Subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
- •Renal impairment
- •Pregnant or lactating females
- •Participation in an investigational drug study within 28 days prior to screening
- •Lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
- •Serious uncontrolled intercurrent infections
- •History of clinically significant coronary artery disease
- •Concomitant treatment with warfarin
- •Known dihydropyrimidine dehydrogenase deficiency
研究组 & 干预措施
Capecitabine RTD
Experimental
干预措施: capecitabine [Xeloda] (Drug)
Capecitabine RTD
Experimental
干预措施: capecitabine RTD (Drug)
Xeloda
Active Comparator
干预措施: capecitabine [Xeloda] (Drug)
结局指标
主要结局
Relative bioavailability: Area under the concentration-time curve (AUC)
时间窗: Multiple sampling pre-dose to 6 hours post-dose
次要结局
- Safety: Incidence of adverse events(30 days)
研究者
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