A multicenter, open label, randomized, balanced, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study of Capecitabine Tablets, USP 500mg manufactured by Amneal Pharmaceuticals, USA and XELODAÂ® (Capecitabine) Tablets 500mg distributed by Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990, following a single oral 2000mg (4x500mg) dose administration in adult human cancer patients under fed condition.

Amneal Pharmaceuticals Ltd0 个研究点目标入组 57 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male or Female 18 to 75 years of age (both inclusive) and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / (height in m)2
•Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer.
•Patients with Dukesâ?? C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
•Patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred
•Patients with metastatic breast cancer resistant to both Paclitaxel and an anthracycline containing chemotherapy regimen or resistant to Paclitaxel and for whom further anthracycline therapy is not indicated.
•Patients who require a daily dose of Capecitabine monotherapy, who are stabilized on twice daily dosing at a dose of 1250 mg/m2 and who have completed at least one cycle of chemotherapy
•Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive).
•Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

•History of allergy or hypersensitivity to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
•Prior unanticipated severe reaction to capecitabine or metabolites and to fluoropyrimidine therapy
•Known hypersensitivity to Ondansetron.
•Pregnant or breastfeeding female
•Geriatric cancer patients ( 80 years)
•History of drug/alcohol addiction
•Known brain metastasis
•Presence of active infections
•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
•Patients receiving concomitant therapy of warfarin, and dihydropyrimidine dehydrogenase deficiency
•Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.

发起方

Amneal Pharmaceuticals Ltd