CTRI/2024/03/063701
已完成
不适用
A Prospective, Randomized, Open Label, Balanced, Single Dose, Two Stage, Two-Treatment, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Cladribine Tablet (Intas Pharmaceuticals Ltd.) Compared with Mavenclad® (EMD Serono, Inc.) in Patients with Relapsing Forms of Multiple Sclerosis.
Invitro Research Solutions Private Limited7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月21日最近更新:
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Invitro Research Solutions Private Limited
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Following primary pharmacokinetic parameters
概览
简要总结
This study is a Prospective, Randomized, Open Label, Balanced, Single Dose, Two Stage, Two Treatment, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Cladribine Tablet (Intas Pharmaceuticals Ltd.) Compared with Mavenclad® (EMD Serono, Inc.) in Patients with Relapsing Forms of Multiple Sclerosis. This study will be conducted in 2 phases: a 21 day screening phase, approximate 2-3 months of intervention phase extending from Day 1 (baseline) barring the delay if any as allowed by the protocol. The duration of individual participation will be approximately 111 days. These are estimated approximate duration calculated based on ideal scenario. Additional safety follow-up visit(s) may be required at monthly interval till month 6 from Day 1 only if the absolute lymphocyte count at EOS visit is below 200 cells/microliter to monitor and record. Each participant will receive study intervention on the Day 1 of each cycle within one treatment course. Participant will be taking Mavenclad on Day 2 to 4/5 (based on individual patient’s dose requirement) of each cycle in the study at home. Sponsor will provide participants with the prescribed reference product. Primary Endpoint is Cmax and AUC0-t, Secondary Endpoint is AUC0-∞, Tmax, AUC_% Exp, R2 adjusted, λz, t1/2 Safety endpoint of the study is Frequency and/or incidence of adverse events (AE) and Serious Adverse Events (SAE).
研究设计
- 研究类型
- Ba/be
- 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
- •1 Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and in this protocol and is willing to participate in the study.
- •2 Man or woman participant must be greater than or equal to 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.
- •3 Body weight greater than or equal to 40 Kg 4 Participants with relapsing forms of multiple sclerosis including relapsing-remitting disease and active secondary progressive disease as per McDonald’s criteria, who are eligible and planned to receive for the first cycle of either first or second treatment course of oral cladribine tablet as per investigator judgement.
- •NOTE: If a participant is receiving their Second Course/First Cycle of oral cladribine under current study, then it must be at least 43 weeks after the last dose of First Course/Second Cycle.
- •5 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a.
- •Is not a woman of childbearing potential (WOCBP) OR a.
- •during the intervention phase and for at least 6 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 6 months after the last dose of study intervention.
- •The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.
- •A WOCBP must have a negative highly sensitive serum pregnancy test at screening and urine pregnancy test before each dosing.
- •If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
排除标准
- •1 Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/excipients thereof (refer to the US prescribing information of Mavenclad), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- •3 Contraindications to the use of study intervention per latest US prescribing information of Mavenclad 4 Current unstable liver or biliary disease with Child-Pugh score less than 6 at screening visit.
- •5 Participant with clinically significant current cardiac conditions like serious cardiac arrhythmia not controlled by adequate medication, electrocardiographic evidence of acute ischemic abnormalities, or any other cardiac illness that could lead to a safety risk to the participant in the opinion of the investigator.
- •6 Positive for HIV, or positive Hepatitis C antibody test or Hepatitis B surface antigen test and/or core antibody test for IgG and/or IgM.
- •7 Evidence of active or latent tuberculosis (TB) as detected by local standard of practice such as imaging and/or positive QuantiFERON-TB Gold test.
- •8 Presence of any clinically significant active systemic bacterial, viral or fungal infections (acute or chronic) as assessed by investigator at randomization.
- •Randomization can be delayed till resolution or control of infection as assessed by investigator allowing use of cladribine tablet.
- •9 Live or live-attenuated vaccine(s) within 6 weeks prior to randomization, or plans to receive such vaccines during the study.
- •10 Current evidence or history of malignancy within the past 3 years except for (a) basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of disease for 3 years; or (b) any malignancy which is considered cured with minimal risk of recurrence AND whose natural history or treatment does not have the potential as judged by the investigator to interfere with the safety of the study intervention are eligible for this study.
结局指标
主要结局
Following primary pharmacokinetic parameters
时间窗: After First Dose
will be assessed:
时间窗: After First Dose
a. Cmax and AUC0-t
时间窗: After First Dose
次要结局
- Following secondary pharmacokinetic(parameters will be assessed:)
- Frequency and/or incidence of adverse(events (AE) and Serious Adverse Events)
研究者
Dr Pande Amitkumar Vardhaman
Medipoint Hospitals Pvt. Ltd.,
研究点 (7)
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