CTRI/2016/01/006508进行中（未招募）不适用
A multicenter open label randomized two treatment two sequence two period crossover oral bioequivalence study of methotrexate tablets USP 2.5 mg ( Test) of Eugia Pharma Specialities Limited India ( A joint venture of Aurobindo Pharma Limited and Celon Laboratories Limited) and methotrexate table USP 2.5 mg ( reference) of Dava Pharmaceuticals Inc USA in adult patients with mild to severe psoriasis or rheumatoid arthritis who are already on established regimens of 2.5 mg every 12 hours under fasting condition
Eugia Pharma Specialities Limited A JV of Aurobindo Pharma Limited and Celon Laboratories Limited6 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年1月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Primary AUC0-12: The area under the plasma concentration versus time curve, from time 0 to 12 hours, as calculated by the linear trapezoidal method. Cmax: Maximum measured plasma concentration over the time span specified.
研究概览
简要总结
This is a multicentre study of Methotrexate 2.5mg tablet for the assessment of Clinical Bio-equivalence as per PK analysis. This is an open label , randomized , two treatment , two sequence , two period crossover oral bioequivalence study of Methotrexate 2.5mg (test) of Eugia Pharma Specialities Limited , India ( A Joint Venture of Aurobindo Pharma Limited & Celon Laboratories Limited) with Methotrexate Tablet USP 2.5mg (Reference of Dava Pharmaceuticals Inc ., USA ) in adult patient with mild to severe psoriasis or Rheumatoid Arthritis in patients who are already on established regimens of 2.5mg every 12 hours under fasting condition .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •Subject aged between 18 to 65 years and of either sex and any race and should have BMI ≥ 18.5 to ≤ 30 kg/m2
- •Diagnosed Subjects with mild to severe psoriasis (has involved body surface area (BSA) ≥ 10 % and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline) or Rheumatoid Arthritis (RA) diagnosed according to the 2010 ACR/EULAR classification criteria (mentioned in appendix 3).
- •Patient with mild to severe Psoriasis or Rheumatoid Arthritis who are receiving Methotrexate 2.5 mg orally every 12 hours for 3 doses (i.e. A total dose of 7.5 mg/week).
- •Subjects agreed to use acceptable methods of birth control as directed by study team.
- •Female subjects of childbearing potential must have a negative pregnancy test at Screening.
- •Subjects having adequate hematologic reserve at screening as per principal investigator/sub investigator assessment.
- •Subjects having adequate and stable hepatic function and renal function at screening as per principal investigator/sub investigator assessment.
- •Patients should be otherwise healthy as determined by physical examination, medical history and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
排除标准
- •1.A female subject, who is pregnant, intends to become pregnant during the study (or within 6 months after study completion) or breast feeding.
- •Patient with fibromyalgia syndrome.
- •Treatment with any investigational drug within 3 months prior to screening.
- •History of infected joint prosthesis within the previous 5 years.
- •Patient with chronic infections like Pneumocystis carinii pneumonia.
- •History of receiving radiotherapy treatment.
- •History or evidence of hypersensitivity to Methotrexate or to Misoprostol or other prostaglandins and its ingredients.
- •History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection.
- •Patient with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
- •Patient diagnosed to be HIV 1 and 2 or Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
- •Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.
- •History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
- •Subject is part of the staff or a family member of the staff personnel directly involved with this study.
- •History of drug abuse.
- •Patient with history of tumor lysis syndrome.
- •Patient is under any treatment which could affect the pharmacokinetic of Methotrexate (Salicylates, Hypoglycaemics, Diuretics, Sulphonamides, Diphenylhydantoins, Tetracyclines, Chloramphenicol and P-aminobenzoic acid, Probenecid, Pencillins, chloroquine, Omeprazole, Etretinate, Co-trimoxazole and Trimethoprim etc.,) administered in past 1 month.
- •Patient is taking prescription of medications listed below: Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin, Leflunomide, Hydroxychloroquine, Cyclosporin or Anti-tumor necrosis factor therapies within 90 days of visit 1 or treatment with Rituximab within 1 year before Visit
- •High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
- •Patient donated blood ≥ 350 mL within 90 days of screening.
结局指标
主要结局
Primary AUC0-12: The area under the plasma concentration versus time curve, from time 0 to 12 hours, as calculated by the linear trapezoidal method. Cmax: Maximum measured plasma concentration over the time span specified.
时间窗: Day 1 and 8 at 0.00 , 0.25, 0.50, 0.75, 1.00, 1.25. 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00 and 12 hours post dose
次要结局
- Tmax: Time of the maximum measured plasma concentration. Kel: Apparent first order elimination rate constant calculated from a semi-log plot of plasma concentration versus time point. T½: The elimination or terminal half-life will be calculated as 0.693 /Kel. Safety and tolerability as assessed by reported adverse events (laboratory and clinical investigations and vital signs)(Day 1 and 8 at 0.00 , 0.25, 0.50, 0.75, 1.00, 1.25. 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00 and 12 hours post dose)
研究者
研究点 (6)
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