An open label, randomized, balanced, two-treatment, two-period, two-sequence, single-dose,crossover, oral bioequivalence study of 60 mg/m2 of Vinorelbine soft capsule from LotusPharmaceutical Co., Ltd., Taiwan compared with that of 60 mg/m2 of NAVELBINEÂ® softcapsule marketed by PIERRE FABRE Limited, Winchester Hampshire S023 7DR, UnitedKingdom, in adult, patients with advanced breast cancer under fed conditions.

otus Pharmaceutical Co 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

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•1.Previously treated advanced breast cancer patient failed on standard treatment of anthracyclins and taxanes.
•2.Patients aged 18 and 65 years (both inclusive).
•3.Patients with ECOG performance status <= 2 and life expectancy of at least 6 months as judged by the investigator.
•4.Patients who have minimum interval of our-weeks between the end of previous chemotherapy and study entry.
•5. Patients who agree to participate in the study and give their informed consent.
•6. Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit.

•1. Patients on previous vinorelbine treatment
•2. Patients on treatment with oral anticoagulants
•3. Patients on treatment with enzyme inducers ( such as ketoconazole and erythromycin) / enzyme inhibitors( such as rifampicin and barbiturates)
•4. Patients with any pre-existing major medical condition.
•5. Patient with current or prior history of evidence of central nervous system metastasis.
•6. Patients with extensive pulmonary and hepatic metastasis.
•7. Patients with pre-existing clinically significant peripheral neuropathy;
•malabsorption syndrome or disease affecting the gastrointestinal tract function.
•8. Patients with previous surgical resection of stomach or small bowel.
•9. Patients with any psychological, family, sociological or geographical conditions hampering medical follow-up or compliance with the study
•10.Patients with history of current or previous use of any recreational drugs or history of drug addiction.
•11.Patients with history of smoking and alcoholism
•12.Difficulty in swallowing capsules/tablets
•13.Patients with severe vomiting.
•14.Patients who are positive for HIV, VDRL/RPR, Hepatitis B & C tests.
•15.Pregnant or lactating women.

发起方

otus Pharmaceutical Co Ltd