500mg卡培他滨片在喂养条件下转移性乳腺癌和结直肠癌患者的比较生物利用度研究

C. Gadiko, S. Tippabhotla, S. Thota, R. Battula, Mukesh Nakkawar, Sandeep Yergude, Sohel Md. Khan, Raju Cheerla, Madhava Rao Betha, V. Vobalaboina
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引用次数: 6

摘要

卡培他滨(口服5-氟尿嘧啶前药)是转移性乳腺癌和结直肠癌的一线治疗药物。该研究的目的是确定Dr. Reddy 's Laboratories Limited的试验产品(卡培他滨片500mg)与罗氏注册公司的参比产品XELODA®(卡培他滨)500mg片在每日两次卡培他滨单药治疗稳定的转移性乳腺癌或结直肠癌患者中的生物等效性。这是一项开放标签、随机、单剂量、双向交叉的饲喂条件下生物等效性研究。受试者在食用高脂肪、高热量早餐30分钟后接受两种治疗(试验或参考),分别在两天(第1天和第2天)根据他们的体表面积进行单次早晨剂量2000毫克的治疗。在给药后10小时采集血液样本,使用经过验证的液相色谱-质谱(LC-MS/MS)方法分析卡培他滨。Cmax、AUC0 - t和AUC0 -∞的最小二乘平均比值和90%置信区间均在80.00-125.00%的监管接受标准范围内,具有生物等效性。
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Comparative bioavailability study of capecitabine tablets of 500 mg in metastatic breast cancer and colorectal cancer patients under fed condition
Capecitabine (oral prodrug of 5-fluorouracil) is the first-line treatment for the metastatic breast and colorectal cancer. The objective of the study was to determine the bioequivalence between the test product (capecitabine tablets 500 mg) of Dr. Reddy’s Laboratories Limited relative to that of reference product XELODA® (capecitabine) 500 mg tablets of Roche Registration Inc. in patients of metastatic breast or colorectal cancer stabilized with twice daily dosing of capecitabine monotherapy. This was an open-label, randomized, single dose, two-way cross-over bioequivalence study under fed conditions. The subjects received either of the treatments (test or reference) 30 min after consumption of a high fat, high calorie breakfast as a single morning dose of 2000 mg on two separate days (days 1 and 2) based on their body surface area. Blood samples were collected up to 10 h post-dose and analyzed for capecitabine using the validated liquid chromatographic mass spectrometric (LC-MS/MS) method. The least square mean ratio and 90% confidence intervals of Cmax, AUC0–t and AUC0–∞ were within the regulatory acceptance criteria of 80.00–125.00% and considered as bioequivalent.
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