CTRI/2024/03/064636进行中（未招募）不适用
A multicenter, randomized, open label, two treatment, two period, 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 Distribution B.V., Netherlands under fasting condition in patients with a confirmed diagnosis of Acute Myeloid Leukemia in remission phase.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 14
- 主要终点
- To demonstrate the
研究概览
简要总结
The purpose of the proposed study is to evaluate bioavailability of Azacitidine Tablets 300 mg and establish bioequivalence between Test product (Azacitdine Tablets 300 mg manufactured by Teva, Czech Industries s.r.o.) and Reference product (ONUREG (Azacitidine) tablets 300mg manufactured by Celgene Distribution B.V., Netherlands) in patients with confirmed diagnosis of Acute Myeloid Leukemia in remission phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of 18 years of age and above at the time of signing the informed consent form.
- •Able to understand and voluntarily sign an informed consent form prior to any study related assessments and procedures.
- •Patients with documented diagnosis of acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery following induction chemotherapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation.
- •Patients who are scheduled to be initiated on maintenance therapy with azacitidine tablets 300mg or already on a stable dose of azacitidine tablets 300mg (for these patients a washout period of 14 days to be maintained prior to the dosing in period I).
- •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.
- •Have an Eastern Cooperative Oncology Group performance status of 0-2, inclusively.
- •Have a life expectancy of more than 3 months based on the clinical judgement of the Investigator.
- •Have stable renal function without dialysis for at least 2 months prior to Investigational Medicinal Product administration.
- •Have adequate bone marrow function at the screening and randomization visits.
- •Have adequate hepatic function at the screening visit.
- •Women of childbearing potential must be non-pregnant or non-lactating.
- •Able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •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.
- •Have been treated with an investigational agent within 4 weeks prior to the first day of IMP administration.
- •Patients treated with proton pump inhibitors like esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole.
- •A positive test result for HIV, HBsAg and HCV.
- •Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator
- •Significant active cardiac disease within the previous 6 months.
- •Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of azacitidine.
- •Uncontrolled systemic fungal, bacterial, or viral infection.
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •Any condition that confounds the ability to interpret data from the study.
- •Impaired ability to swallow oral medication.
结局指标
主要结局
To demonstrate the
时间窗: Day 2
bioequivalence between Test
时间窗: Day 2
product Azacitidine 300mg
时间窗: Day 2
tablets and Reference product
时间窗: Day 2
ONUREG® (Azacitidine)
时间窗: Day 2
300mg tablets in patients with
时间窗: Day 2
Acute Myeloid Leukemia
时间窗: Day 2
次要结局
- To monitor safety & tolerability(1) Adverse events)
研究者
Mr Saravanan Gurumurthy
Lotus Labs Pvt. Ltd.
研究点 (14)
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