CTRI/2024/11/076347已完成不适用
A randomized, open label, balanced, multicenter, two-treatment, four-period, two-sequence, single-dose, full-replicate, cross-over bioequivalence study of Azacitidine 300 mg film-coated tablets compared to ONUREG 300 mg film-coated tablets in adult patients with Acute Myeloid Leukaemia (AML) under fasting conditions.
Synthon B.V.12 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- To establish bioequivalence between Azacitidine 300 mg tablets (Test) and ONUREG 300 mg film-coated tablets (Reference) in adult patients with acute myeloid leukaemia (AML).
研究概览
简要总结
This is a full replicate bioequivalence study between test and reference product in patients diagnosed with acute myeloid leukaemia (AML) (from multiple sites in India)Patients will be randomly allocated to a treatment sequence of TRTR or RTRT.
The study consists of a screening period of 10 days and four treatment periods of 1 day each in the same treatment cycle; Period I on Day 1, Period II on Day 2], Period III on Day 3, and Period IV on Day 4.
Total duration of study will be 14 days (approximately) consists of a screening period of 10 days prior to first study drug administration wherein:
ü Check in on Day 0 (12 hours prior to drug administration of Day 1)
ü Study drug administration on Day 1 (period-I), Day 2 (period-II), Day 3 (period-III) and Day 4 (Period-IV)
ü Hospitalization on Day 0 (Check-in) to Day 4 (Check-out) in the study. For patient convenience, check-out may be done on Day 5 at the discretion of Investigator.
ü PK Sampling onDay 1 to Day 4 of the study.
ü End of the study after last PK sample collection on Day 4.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Able to give written informed consent for participation in the trial.
- •Patients with documented diagnosis of acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy with or without consolidation therapy.
- •Patients meeting either one of the following criteria: • Patients that will be initiating treatment with Azacitidine 300 mg tablets as per the independent clinical judgement of the investigator. Or • Patients that are already receiving a stable dose of 300 mg Azacitidine
- •Patients with a history of treated brain metastases should be clinically stable for more than and equal to 4 weeks prior to signing the informed consent. Glucocorticoid therapy for central nervous system -CNS edema is permitted if the dose is less than or equal to 20 mg of prednisolone or equivalent .
- •Patients who are not eligible for or choose not to proceed to, hematopoietic stem cell transplantation -HSCT
- •Patients having a life expectancy of more than 3 months.
- •Adequate organ and bone marrow function based upon the following laboratory criteria at the time of eligibility assessment Hemoglobin more than and equal to 8.0 g/dL Absolute neutrophil count more than and equal to 1000/uL Platelet count more than and equal to 75,000/uL Creatinine Clearance more than and equal to 30 mL/min -calculated based on Cockcroft-Gault formula Total Bilirubin ï‚£ 1.5 times ULN SGOT.
- •AST 2.5 times ULN SGPT.
- •ALT 2.5 times ULN
- •Eastern Cooperative Oncology Group -ECOG performance status of 0-2 both inclusive.
- •12-lead ECG with no clinically significant findings at screening as determined by the Investigator.
- •Women of child bearing potential, unless surgically sterile -at least 6 months prior to study drug administration or postmenopausal for at least 12 consecutive months, must have negative pregnancy test at screening visit and before randomization; and must agree to use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and up to 6 months after the last dose of study drug administration. Cessation of birth control after this point should be discussed with a responsible physician.
- •In case of male patients: The patient must agree to use an effective method of contraception for at least 4 weeks prior to first study dose administration up to at least 3 months after the last dose of study drug administration.
- •Patients that are willing to comply with the study procedures in the opinion of Investigator.
排除标准
- •Patients who meet any of the following exclusion criteria at screening will not be enrolled in the study:
- •History of known hypersensitivity to Azacitidine or its components which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
- •Patients found positive for HIV, VDRL or RPR -for syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Medicinal Product -IMP administration.
- •History of inflammatory bowel disease -e.g. Crohn s 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 patient to an increased risk of gastrointestinal toxicity.
- •Patients with severe renal impairment.
- •Patients with severe hepatic impairment
- •Patients treated with proton pump inhibitors-PPIs- like Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole and Rabeprazole within 4 weeks prior to start of IMP or require as concomitant medication.
- •In the opinion of the Investigator, the patient will not be compliant with the requirements of the study procedures.
- •Participation in another drug research study within 90 Days-or 5 half-lives, whichever is longer prior to receiving the first dose of investigational medicinal product for the current study.
- •History of difficulty in accessibility of veins.
- •Patient positive on Breath alcohol analyzer test at the time of screening and Check in Day
- •Positive for drugs of abuse at the time of screening and Check in Day
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the patient in case of participation in the study.
- •Patients with psychiatric illness social situations that would limit compliance with study requirements.
- •Patients with any uncontrolled medical condition e.g., cardiovascular disease, hypertension, diabetes mellitus etc.
- •or active infection, etc or any abnormal laboratory findings, which, in the Investigator s opinion, would contraindicate, or interfere with absorption of the study drug or jeopardize the safety of the patient.
- •Patients with impaired ability to swallow and retain oral medication.
- •Patients with uncontrolled systemic fungal, bacterial, or viral infection patients.
结局指标
主要结局
To establish bioequivalence between Azacitidine 300 mg tablets (Test) and ONUREG 300 mg film-coated tablets (Reference) in adult patients with acute myeloid leukaemia (AML).
时间窗: Day 1 - Period I, Day 2- Period II, Day 3 - Period | III and Day 4 - Period IV: (full replicate BE study, | each period is for 1 day)
次要结局
- To monitor the adverse events and to ensure the safety of the patients(Day 1 - Period I, Day 2- Period II, Day 3 - Period)
研究者
Dr Rakesh Patel
Veeda Clinical Research Limited
研究点 (12)
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