CTRI/2025/08/092636尚未招募不适用
A multi-centre, open label, balanced, randomised, two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady state, pharmacokinetic endpoint bioequivalence study of niraparib tablets 2x100 mg of Natco Pharma Ltd. (test product) against Zejula (niraparib) tablet 2x100 mg of GlaxoSmithKline (Ireland) (reference product) under fasting conditions in female participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 18
- 主要终点
- To establish the bioequivalence between Niraparib tablets 200mg of Natco Pharma - test formulation and ZEJULA –niraparib tablet 200 mg of GlaxoSmithKline - reference productunder fasting conditions in female patients with advancedepithelial ovarian, fallopian tube, or primary peritoneal cancerwho are in a complete or partial response to first-lineplatinum-based chemotherapy.
研究概览
简要总结
A bioequivalence study between test and reference products in female patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy that are receiving market available products of Niraparib tablets 200 mg once daily or are eligible to receive Niraparib tablets 200 mg once daily.
The patients will undergo screening within 28 days prior to first dose administration.
Treatment Period: 20 days
The patients who are found eligible will participate in the study.
Two consecutive steady state full PK profiles will be obtained after administration of each treatment -i.e., Test & Reference in this study
In period I -Day 1 to Day 10, patients will receive either Test product or Reference product and in period II -Day11-20 alternate treatment arm will be received by the patient.
Safety assessment: Day 21 ±2 or at the time of early discontinuation of the subject.
Safety follow-up / End of study assessment: Day 28 ± 2
Total 42 blood samples of 03 mL each will be collected during the study.
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
- Female
入选标准
- •Non-pregnant, non-lactating female participants with age greater than and equal to 18 years and less than equal to 65 years with BMI ranging from 18.5 to 28 kg/m2 (Both inclusive).
- •Participants with confirmed diagnosis.
- •documented evidence of histopathological/ cytological confirmed of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and are eligible to receive niraparib as maintenance therapy and participants having weight criteria of greater than 48 kg (106 lb) and less than 77 kg (170 lbs).
- •Participants must have undergone a CT scan within 6 weeks prior to screening in the study.
- •Participants meeting either one of the following criteria: • Participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that will be initiating treatment with niraparib tablets 2x100 mg as per the independent clinical judgement of the investigator. Or • Participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are already receiving niraparib 2x100 mg are also eligible.
- •Participants who are non-smokers and ex-smoker (an ex-smoker is defined as someone who has completely stopped using nicotine products for at least 90 days prior to study drug administration).
- •Participants who provide written informed consent for participation in the study.
- •Acceptable adequate organ and bone marrow function at screening and randomisation defined by: -Bone marrow function & haematology a) Haemoglobin greater than and equal to 9.0 g/dL b) Neutrophil count greater than and equal to 1,500 /uL c) Platelet count greater than and equal to 150,000/uL -Renal function Creatinine Clearance greater than and equal to 30 mL/min.
- •calculated based on Cockcroft-Gault formula -Hepatic function Total Bilirubin less than 1.5 times ULN SGOT (AST) less than 2.5 times ULN SGPT (ALT) less than 2.5 times ULN
- •Able to take oral medication without crushing, dissolving, or chewing tablets.
- •Participants must have a life expectancy of greater than and equal to 6 months.
- •Participants who received prior radiation therapy or underwent surgery, at least 28 days must have elapsed since completion of radiation therapy or surgery and participant must have recovered from all side effects at the time of screening (e.g., back to baseline or grade 1).
- •Participants who are willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up to implement safety precautions and monitoring including complete blood count during treatment.
- •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 non-childbearing potential with documented evidence of surgical sterility at least 6 months prior to IMP administration) or postmenopausal (defined as 12 consecutive months of spontaneous amenorrhea without other medical explanation) for at least one year. OR Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or total abstinence (not the periodic abstinence) for at least 4 weeks prior to study drug administration, during the study and for 6 months after the last dose of study drug administration. Cessation of birth control after this point should be discussed with a responsible physician. 15.Participants that can comply with the study procedures in the opinion of Investigator. Participant/ caregiver must be able to communicate effectively with study personnel or investigator.
排除标准
- •Female participants who are pregnant, lactating, or actively breastfeeding
- •Participants who require dosage modification or with expected changes in concomitant medications that may potentially affect the pharmacokinetics of niraparib during the study.
- •Participants with known hypersensitivity/ intolerance to study drug or any other component of the drug or intolerance to niraparib.
- •History of other malignancies in the last 05 years (except in situ cancer or basal or squamous cell skin cancer).
- •Known CNS metastasis (screened by contrast brain MRI) or history of previously treated brain metastases that required local treatment.
- •Participant has significant pleural effusion or ascites that is expected to require drainage during the pharmacokinetic phase of study.
- •If participant has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Participants with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption or presence of a gastrointestinal condition (significant gastrointestinal resection) that is likely to interfere with drug absorption.
- •Participants taking strong and/or moderate CYP3A4 inducers or strong and/or moderate CYP3A4 inhibitors within 30 days of screening and throughout the study.
- •History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- •Participants who have had the following less than or equal to 28 days prior to first dosing in Period I: a.
- •A transfusion (platelets or red blood cells) b.
- •A myelosuppression or bone marrow suppression c.
- •Major surgery
- •Blood loss (1 unit or 350 ml) within 90 days prior to first dosing in Period I for the current study
- •History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to direct venipuncture.
- •Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- •Receipt of any investigational medicinal product or participation in another drug research study involving IMP administration within 3 months/ 5 half-lives (whichever is longer) prior to first dosing in Period I for the current study.
- •Participants found positive for HIV, VDRL or RPR (for syphilis), Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •Severe bone injury caused by tumour bone metastases as judged by the Investigator, including severe bone pain due to poor control, pathological fracture of important parts or spinal cord compression occurred in the last 6 months or expected to occur in the near future.
- •Participants with moderate or severe hepatic impairment (Child Pugh Class B and C) in screening.
- •Participants with a prior history of pulmonary embolism or venous thrombosis, arrhythmia, hypokalaemia or haemorrhage.
- •Participants with history of Posterior reversible encephalopathy syndrome (PRES) or at risk of developing Posterior reversible encephalopathy syndrome (PRES) as per the discretion of the Investigator.
- •Participants with uncontrolled diabetes mellitus and hypertension judged by investigator.
- •Participants positive on Breath alcohol analyzer test during screening and at the time of baseline/randomization visit.
- •Participants positive on urine test for drugs of abuse during screening and at the time of baseline/randomization visit.
- •Difficulty in swallowing tablets.
- •Problems with fasting.
- •Any other medical condition or serious inter-current illness that, in the opinion of the Investigator, may make it undesirable for the participant to participate in the study but not limited to cirrhosis or psychiatric illness/social situations or would limit adherence to study requirements.
- •Immunocompromised participants.
结局指标
主要结局
To establish the bioequivalence between Niraparib tablets 200mg of Natco Pharma - test formulation and ZEJULA –niraparib tablet 200 mg of GlaxoSmithKline - reference productunder fasting conditions in female patients with advancedepithelial ovarian, fallopian tube, or primary peritoneal cancerwho are in a complete or partial response to first-lineplatinum-based chemotherapy.
时间窗: To establish the bioequivalence between Niraparib tablets 200mg of Natco Pharma - test formulation and ZEJULA –niraparib tablet 200 mg of GlaxoSmithKline - reference productunder fasting conditions in female patients with advancedepithelial ovarian, fallopian tube, or primary peritoneal cancerwho are in a complete or partial response to first-lineplatinum-based chemotherapy.
次要结局
- To assess the safety & tolerability of the test product compared to reference product by monitoring adverse events.(safety & tolerability of the test or reference product evaluable up to day 28 during the study)
研究者
Dr Rakesh Patel
Veeda Clinical research Limited
研究点 (18)
Loading locations...
相似试验
尚未招募
不适用
A bioequivalence study of Niraparib tablets 200 mg in female patients with Ovarian CancerCTRI/2025/01/079290NATCO Pharma Limited62
已完成
不适用
A study of Azacitidine 300 mg tablets in adult patients with Acute Myeloid Leukemia (AML) .CTRI/2024/11/076347Synthon B.V.60
招募中
Unknown
Hormonal Intrauterine Contraceptive DevicesFiona is intended for contraception. It can also be used in idiopathic menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy.CTRI/2025/03/082696Meril Life Sciences Pvt Ltd140
招募中
不适用
A bioequivalence study of Niraparib tablets 200 mg in female patients with ovarian, fallopian tube or peritoneal cancer.CTRI/2025/07/090599Lek Pharmaceuticals d.d.34
已完成
4 期
Bioequivalence clinical trial of two formulations of ezetimibe/atorvastatin2023-504987-40-00Laboratorios Normon S.A.14