A multicenter, randomized, open label, two treatment, three period, reference replicated, single-dose, crossover, bioequivalence study of Azacitidine Tablets 300 mg manufactured by Teva, Czech Industries s.r.o. with ONUREG (Azacitidine) Tablets 300 mg manufactured by Celgene Corporation, USA under fasting condition in patients with a confirmed diagnosis of Acute Myeloid Leukemia in remission phase.

Watson Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

阶段: 未知
状态: 招募中
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Ba/be

入排标准

入选标准

•1. Male and female patients more than 18 years of age at the time of signing the informed consent form.
•2. Understand and voluntarily sign an informed consent form prior to any study related assessments-procedures are conducted.
•3. Patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy with or without consolidation chemotherapy and who are not eligible for hematopoietic stem cell transplantation.
•4. As per investigator discretion, patients must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population.
•5. Patients with a history of treated central nervous system involvement should be clinically stable for more than 4 weeks prior to signing the informed consent. Glucocorticoid therapy for central nervous system edema is permitted if less than 20 mg per day of prednisolone or equivalent.
•6. Have an Eastern Cooperative Oncology Group performance status of 0-2, inclusively.
•7. Have a life expectancy of more than 3 months.
•8. Have stable renal function without dialysis for at least 2 months prior to Investigational Product.
•9. Have adequate bone marrow function at the screening and randomization visits
•10. Have a 12-lead Electrocardiogram with no clinically significant findings at screening, as determined by the investigator.
•11. Women of child bearing potential must be non-pregnant or non-lactating.
•12. Able to adhere to the study visit schedule and other protocol requirements.

排除标准

•1. Gastrointestinal tumors, tumors that have originated or metastasized to the liver, or other tumors known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease any previous aforementioned treatments within 4 weeks of period 1 dosing.
•2. Have been treated with an investigational agent within 4 weeks prior to the first day of IP administration
•3. Patients treated with proton pump inhibitors like esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole within 4 weeks prior to start of IMP or require as concomitant medication.
•4. A positive test result for any of the following- HIV, Hepatitis B surface antigen, Hepatitis C, VDRL, drugs of abuse and breath alcohol test during check-in.
•5. Have ongoing clinically significant adverse events due to prior treatments administered as determined by the investigator.
•6. Significant active cardiac disease within the previous 6 months, including
•7. Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of Azacitidine.
•8. Uncontrolled systemic fungal, bacterial, or viral infection defined as ongoing signs-symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and-or other treatment.
•9. History of inflammatory bowel disease e.g. Crohns disease, ulcerative colitis, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and-or predispose the subject to an increased risk of gastrointestinal toxicity.
•10. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•11. Any condition that confounds the ability to interpret data from the study
•12. Impaired ability to swallow oral medication

研究者

发起方

Watson Pharma Pvt Ltd

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