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:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Following primary pharmacokinetic parameters
研究概览
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
- 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
- •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.
- •In such cases, the participant must be excluded from participation if the serum pregnancy result is positive The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •6 Male participants are eligible to participate if they agree to the following during the intervention phase and for at least 6 months after the last dose of study intervention: a.
- •Must agree not to donate sperm for the purpose of reproduction PLUS EITHER: b.
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR a.
- •Must agree to use contraception /barrier as detailed below b.
- •A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person.
- •Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant 7 Participant with adequate hematologic, and renal function at screening visit a.
- •Absolute lymphocyte count between 1000-4000 cells/microliter before initiating the first treatment course OR greater than 800 cells/microliter before initiating the second treatment course at screening visit.
- •Estimated creatinine clearance Greater than or equal to 60 mL/min as estimated by the Cockcroft-Gault formula 8 Willing and able to adhere to the lifestyle restrictions specified in this protocol.
- •9 Participants who are seronegative to VZV must be vaccinated with varicella vaccine (live or live attenuated) prior to initiation of study intervention.
- •If participant has received varicella vaccine (live or live attenuated) in the past or seropositive to VZV at screening, they must agree to be vaccinated with recombinant, adjuvanted vaccine during screening phase and throughout the study period if applicable.
- •Investigators must review and confirm vaccinations and immunizations status.
- •Participants may be rescreened in case of any pending vaccination(s).
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.
- •Baseline MRI is required during screening period if not done in past 3 months prior to administration of study intervention if it is the participant’s first treatment course.
- •12 Received a study intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to randomization, whichever is longer.
- •13 Participant’s clinical condition would not be feasible for pharmacokinetic assessment as determined by investigator.
- •14 Unable to swallow solid, oral dosage forms whole with the aid of water (participants must not chew, divide, dissolve, or crush the study intervention).
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)
Loading locations...
相似试验
尚未招募
不适用
ORAL BIOEQUIVALENCE STUDY OF HYDROXYUREA CAPSULES, USP 500 MG COMPARED WITH HYDREA® (HYDROXYUREA CAPSULES, USP) 500 MG IN ADULT, HUMAN PATIENTS WITH SICKLE CELL ANEMIA UNDER FASTING CONDITIONS.CTRI/2025/09/095472Esjay Pharma Pvt. Ltd.36
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
尚未招募
2 期
A Phase II Study of Neoadjuvant Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab in Locally Advanced Cervical CancerCervical CancerNCT07348861Zheng Min25
已完成
不适用
An open label, multicenter, randomized, balanced, two treatment, two sequence, two period, crossover, single dose, pharmacokinetic, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial in metastatic breast cancer patients.CTRI/2025/02/079937Hetero Labs Limited20
尚未招募
不适用
Bioequivalence study of Olaparib Tablets 150 mg (2x150 mg tablets) with Lynparza® 150 mg Film-coated tablets (Olaparib (2x150 mg tablets)) in adult patients with carcinoma of the ovary, breast, prostate or adenocarcinoma of the pancreas under fasting condition.CTRI/2025/07/091607Qilu Pharmaceutical (Hainan) Co., Ltd.40