A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India) to the reference listed drug XelodaÂ® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) in patients of Breast Cancer or Colorectal Cancer under fed condition. - NA

Intas Pharmaceuticals Ltd India0 个研究点目标入组 118 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2.
•2.Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer.
•3.Patients with BSA between 1.26-1.91 (Both inclusive) should be included.
•4.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
•5.Patient with adequate bone marrow, renal and hepatic function.
•6.Adequate Cardiac function (left ventricular ejection fraction [LVEF] >=50%).
•7.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
•8.Patients with life expectancy of at least 3 months.
•9.Able to comply with study requirement in opinion of Principal Investigator.
•10.Able to give written informed consent for participation in the trial.
•11.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 0 must be negative.

•Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to
•5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
•2. Pregnant or breast-feeding female
•3. Any of the following cardiac conditions:
•a. Unstable angina
•b. Myocardial infarction within the past 6 months
•c. NYHA (New York State Heart Association) class II-IV heart failure
•d. Severe uncontrolled ventricular arrhythmias
•e. Clinically significant pericardial disease
•f. Electrocardiographic evidence of acute ischemic or active conduction system
•abnormalities
•g. Any other cardiac illness that could lead to a safety risk to the patient in case of
•enrolment in the study
•4. History of drug/alcohol addiction
•5. Known brain metastasis

发起方

Intas Pharmaceuticals Ltd India