CTRI/2021/09/036201已完成未知
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Period, Two-Sequence, Two-Way Crossover, Oral Bioequivalence Study of Cladribine Tablets 10 mg manufactured by Arab Pharmaceutical Manufacturing Company, Jordan for Hikma Pharmaceuticals, Jordan (MAH) and MAVENCLAD® (Cladribine) Tablets 10 mg manufactured by NerPharMa S.R.L., Italy for Merck Europe B.V., Netherlands (MAH) in 40 adult patients with highly active relapsing multiple sclerosis (MS) under fasting conditions. - Not Applicable
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Adult patients who are diagnosed with highly active relapsing multiple sclerosis (MS) according to the McDonald criteria at the time of screening as per the principal investigator.
- •2.Male or female, between 18 and 65 years of age.
- •3.Weighed between 40-99 kilogram (kg).
- •4.Subject with Lymphocyte count normal as per lower limit of normal range (of the central laboratory) for Year 01 treatment and greater than 800 cells/mm³ for Year 02 treatment.
- •5.Has a physical condition which enable patients to be fit for a Pharmacokinetic sampling according to principal investigator evaluation.
- •6.If female, she must:
- •be post-menopausal or surgically sterilized; or
- •uses a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study and willing to continue the same for 6 months from the last dose.
- •And be neither pregnant nor breast-feeding.
- •7.If male, he must be willing to use contraception to avoid pregnancies during the study and willing to continue the same for 6 months from the last dose.
- •8.Be willing and able to comply with study procedures for the duration of the study
- •9.Able to understand and willing to sign written informed consent form.
排除标准
- •1.Has significant leukopenia (white blood cell count less than 0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1.
- •2.Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1.
- •3.Has compromised immune function or infection.
- •4.Has received cytokine-based therapy, intravenous immunoglobulin therapy, or plasmapheresis within 3 months prior to Study Day 1.
- •5.Has platelet and absolute neutrophil counts below the lower limit of normal range within 28 days prior to Study Day 1.
- •6.Has prior or current history of malignancy.
- •7.Has systemic disease that, in the opinion of the Investigator, might interfere with subject safety, compliance or evaluation of the condition under Study (for example, insulin-dependent diabetes, clinically significant cardiac disease, moderate or severe hepatic impairment, moderate or severe renal impairment (creatinine clearance <60 mL/min).
- •8.Has a psychiatric disorder that, in the opinion of the Investigator, was unstable or would preclude safe participation in the study.
- •9.Has allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients.
- •10.Has used any investigational drug or experimental procedure within 6 months prior to Study Day 1.
- •11.Patients who has been vaccinated with any live or attenuated live vaccines within 4 to 6 weeks of screening.
- •12.Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and opiates-OPI).
- •13.Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus or COVID 19 reactive/positive.
- •14.Patients who have a history or active Tuberculosis and patients who have no history of exposure to varicella zoster virus.
研究者
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