CTRI/2024/09/073306进行中（未招募）不适用
A randomized, open-label, balanced, multi-center, two-treatment, four-period, two-sequence, single dose, crossover, fully replicate, bioequivalence (BE) study of Azacitidine tablets 300 mg of Qilu Pharmaceutical Co., Ltd with ONUREG (Azacitidine) tablets 300 mg of Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, 86 Morris Avenue, Summit, NJ 07901 in patients with Acute Myeloid Leukemia.
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
- 16
- 主要终点
- To assess the bioequivalence of Azacitidine tablets 300 mg of Qilu Pharmaceutical Co., Ltd with ONUREG (Azacitidine) tablets 300 mg of Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, 86 Morris Avenue, Summit, NJ 07901
研究概览
简要总结
This is a randomized, open-label, balanced, multi-center, two-treatment, four-period, two-sequence, single dose, crossover, fully replicate, bioequivalence (BE) study of Azacitidine tablets 300 mg of Qilu Pharmaceutical Co., Ltd with ONUREG (Azacitidine) tablets 300 mg of Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, 86 Morris Avenue, Summit, NJ 07901 in patients with Acute Myeloid Leukemia.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent prior to any study-related activities being performed and to follow the protocol requirements
- •Male and female subjects aged 18 years or older and having Body Mass Index between 18.00 to 30.00 kg per m2 (both inclusive)
- •Subjects with diagnosis of Acute Myeloid Leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy and who will be initiating the treatment of Azacitidine 300 mg tablets or Subjects who are already receiving Azacitidine 300 mg tablets treatment Note: Subjects will receive period 1 study treatment on Day 1 of the 28 day treatment cycle.
- •Able to swallow and retain oral medication
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •The life expectancy of greater than 90 days
- •Acceptable hematology status a.
- •Hemoglobin greater than or equal to 8 g per dL b.
- •Absolute neutrophil count (ANC) greater than or equal to 500 cells per micro L Or ANC greater than or equal to 500 cells per micro L without occurrence of ANC less than 500 cells per micro L in previous two Consecutive Cycles (applicable if subject has received greater than 1 cycle) c.
- •Platelet count greater than or equal to 50000 cells per micro L Or Platelet count greater than or equal to 50000 cells per micro L without occurrence of Platelets less than 50000 cells per micro L with bleeding in previous two Consecutive Cycles (applicable if subject has received greater than 1 cycle)
- •Acceptable liver function Bilirubin less than or equal to 1.5 X ULN
- •Subjects with creatinine clearance by Cockcroft-Gault equation greater than or equal to 45 mL per minute as mentioned in study protocol for males and females.
- •Females of childbearing potential with a negative serum pregnancy test at screening and negative urine pregnancy test at the time of check-in
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction
- •Male subjects must agree to use acceptable methods of contraception during the study and for at least 3 months after the last dose
- •Women of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing two acceptable methods of contraception during the study and for at least 06 months after the last dose Acceptable methods of contraception are a.
- •Oral, parenteral, patch, or implant hormonal contraception b.
- •Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) d.
- •Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) e.
- •Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation f.
- •Total abstinence, partial abstinence is not acceptable.
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •Hypersensitivity to azacitidine or any other ingredient used in the manufacture of oral azacitidine
- •Suspected or proven acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
- •History of malignancy except disease under study, within the past 1 year except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix or Chronic myelomonocytic leukemia (CMML); or malignancy, which is considered cured with minimal risk of recurrence
- •History or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, etc.)
- •Presence of myelosuppression (except if eligible as per inclusion criteria number 7) or Myelodysplastic Syndromes
- •Use of any proton pump inhibitor (i.e. omeprazole) or any other agent that may affect gastric acid level and cytidine deaminase inhibitor (i.e. cedazuridine) within 14 days or five half-lives of the inhibitory effect prior to start of study therapy or is required during the study
- •Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
- •Subjects who have participated in any clinical trial with another investigational drug or other investigational intervention within 90 days of enrolment in the study
- •Loss of ≥ 350 mL (1 unit) of blood within 90 days before enrolment in the study
- •Subjects with positive serology for Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
- •Subjects with positive urine screen for drugs of abuse (including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, and morphine)
- •Subjects with positive urine alcohol test
- •Pregnant or lactating women.
结局指标
主要结局
To assess the bioequivalence of Azacitidine tablets 300 mg of Qilu Pharmaceutical Co., Ltd with ONUREG (Azacitidine) tablets 300 mg of Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, 86 Morris Avenue, Summit, NJ 07901
时间窗: A total of fifteen (15) blood samples (Pre-dose 00.00 Hrs, 00.17 Hrs (10 mins), 00.33 Hrs (20 Mins), 00.67 (40 Mins), 01.00 Hrs, 01.33 Hrs, 01.67 Hrs, 02.00 Hrs, 02.50 Hrs, 03.00 Hrs, 03.50 Hrs, 04.00 Hrs, 05.00 Hrs, 06.00 Hrs and 08.00 Hrs) of 03.0 mL each will be collected for PK analysis in each period of the study. A total of 60 blood samples will be collected during the study.
次要结局
- To compare the pharmacokinetic of Azacitidine tablets 300 mg of Qilu Pharmaceutical Co., Ltd with ONUREG (Azacitidine) tablets 300 mg of Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb, 86 Morris Avenue, Summit, NJ 07901.(To monitor the adverse events and to ensure the safety of patients.)
研究者
Dr Sandeep Singh
CBCC Global Research LLP
研究点 (16)
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