Single-Dose Fed Relative Bioavailability Study of Two Formulations of Mylan’s Capecitabine Extended-release Tablets to Immediate-release Capecitabine Tablets in Adult Cancer Patients with Advanced or Metastatic Breast Cancer, Stage III Colon Cancer, or Unresectable or Metastatic Colorectal Cancer Receiving a Capecitabine Dose of 2000 mg/m2/day or 2500 mg/m2/day
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Relative bioavailability of two extended-release formulations of Mylan’s Capecitabine Extended-release Tablets following a single, oral dose of 2500 mg/m2/day or 2000 mg/m2 dose to reference immediate-release Capecitabine Tablets following a single oral dose of 1250 mg/m2 or 1000 mg/m2 will be evaluated by comparison of various pharmacokinetic parameters derived from the plasma concentration time curves (e.g. AUCL, AUCINF, and CPEAK) of capecitabine.
研究概览
简要总结
A single dose pharmacokinetic study will be performed which will compare two formulations of Mylan’s Capecitabine Extended-release Tablets, 150 mg & 1000 mg to immediate-release Capecitabine Tablets, 150 mg & 500 mg (Reference product), under fed conditions in adult cancer patients with advanced or metastatic breast cancer, stage III colon cancer, or unresectable or metastatic colorectal cancer receiving a dose of capecitabine of 2500 mg/m2/day or 2000 mg/m2 dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are receiving stable doses of capecitabine as a single agent for advanced or metastatic breast cancer, adjuvant treatment of colon cancer, or for unresectable or metastatic colorectal cancer.
- •Patients must have completed at least one 21-day cycle of capecitabine.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •Age between 18 and 65 years
- •Sex: Females of non-childbearing potential and Males.
排除标准
- •Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
- •Individuals with rapidly progressing disease, especially with visceral organ involvement.
- •Individuals requiring a change in dose or regimen of either capecitabine.
- •History of unstable or clinically significant gastrointestinal disease, including a history of chronic diarrhea, inflammatory bowel disease, unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting).
- •History of unstable or clinically significant cardiovascular disease, hepatic, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or other malignancies.
- •Subjects receiving capecitabine for the treatment of gastric, esophageal or gastroesophageal junction cancer or pancreatic cancer.
- •ECOG performance status ≥ 3
- •Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2
- •Donation or loss of blood or plasma.
结局指标
主要结局
Relative bioavailability of two extended-release formulations of Mylan’s Capecitabine Extended-release Tablets following a single, oral dose of 2500 mg/m2/day or 2000 mg/m2 dose to reference immediate-release Capecitabine Tablets following a single oral dose of 1250 mg/m2 or 1000 mg/m2 will be evaluated by comparison of various pharmacokinetic parameters derived from the plasma concentration time curves (e.g. AUCL, AUCINF, and CPEAK) of capecitabine.
时间窗: PK sampling: From pre-dose till 24 hours in each period administration.
次要结局
- To assess the safety & tolerability of Capecitabine Extended-release Tablets in cancer patients(Safety & tolerability of Capecitabine Extended-release Tablets in cancer patients will be assessed from Screening till day 12 (End of study).)
研究者
Dr Sandeep Singh
CBCC Global Research LLP