A multicentre, randomized, open label, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Hetero Labs Ltd, India) and the reference listed drug XelodaÂ® (Capecitabine) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080) in locally advanced or Metastatic Breast Cancer or Colorectal Cancer adult subjects already receiving a stable twice-daily dosing regimen as prescribed by the reference product label under fed condition.

Hetero Labs Ltd0 个研究点目标入组 64 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.Established cases of advanced breast cancer or metastatic breast cancer or colo-rectal cancer who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet.
•2.Life expectancy of at least 3 months
•3.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

•1. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
•2. Positive alcohol or drug abuse test at baseline.
•3. Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively.
•4. Have received any live or live attenuated vaccines within 2 months prior to randomization.

发起方