A multicentre, randomized, open label, two treatment, two period, two-sequence, crossover, multiple dose, steady state bioequivalence study under fasting conditions comparing Everolimus tablets 10 mg (Manufactured by: ROXANE LABORATORIES, INC., Wilson Road, Columbus, Ohio 43228) to the reference listed drug AFINITORÂ® 10 mg tablets (Manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936) in patients of Advanced Renal Cell Carcinoma stabilized on Everolimus 10 mg.

ROXANE LABORATORIES INC0 个研究点目标入组 46 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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•Patients willing to give written informed consent for participation in the trial.
•Patients must have an ECOG performance status of 0-2.
•Patients with diagnosis of advanced renal cell carcinoma (RCC).
•Patients should be able to comply with study procedures in the opinion of the investigator.
•In the case of female patients, the serum pregnancy test at the screening visit and the urine pregnancy test at Day 1 (before dosing) must be negative.
•Patients willing to avoid use of any recreational drugs/tobacco products/alcohol during the study (from screening to end of the study)

•Known hyper-sensitivity to Everolimus or to other Rapamycin derivatives or any of its excipients.
•Patients with human immunodeficiency virus (HIV) infection.
•A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
•Use of any recreational drugs or history of drug addiction.
•Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data
•Patients with a history of difficulty in donating blood or difficulty in accessibility of veins.
•Female patients who are lactating.

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