CTRI/2021/08/035480已完成不适用
An Open-Label, Randomized, Single-Dose, Two-Period, Two-Treatment, Two-Sequence, Crossover, Multicenter, Bioequivalence Study of Two Formulations of Methotrexate Tablets USP 2.5mg in Patients with Mild to Severe Psoriasis or Rheumatoid Arthritis Under Fasting Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Cmax: Maximum measured plasma
研究概览
简要总结
This is an open-label, randomized, single-dose,two-period, two treatment, two-sequence, crossover, multicenter bioequivalence studyin patients with mild to severe psoriasis or rheumatoid arthritis under fastingcondition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient will be eligible for inclusion in this study only if all of the following criteria apply:
- •Male or non-pregnant, non-lactating female between 18-65 years of age (both inclusive).
- •Male patient if sexually active with a female of child bearing potential must agree to use barrier method of contraception throughout the study period and for at least 3 months after last dose of study drug.
- •Female of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & urine pregnancy test at the time of check-in of each period.
- •Female patient of childbearing potential must use highly effective methods of contraception throughout the study period and agree to continue contraception for at least 6 months after the last dose of study drug.
- •Acceptable forms of contraception include the following: i.
- •Intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii.
- •Barrier methods containing or used in conjunction with a spermicidal agent, or iii.
- •Surgical sterilization, or iv.
- •Practice sexual abstinence throughout the course of the study.
- •Female will not be considered of child bearing potential if one of the following is reported and documented in the medical history: i.
- •spontaneous amenorrhea for at least one year, or ii.
- •6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL, or iii.
- •at least 6 weeks post-surgery following bilateral oophorectomy with or without hysterectomy.
- •Patient should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18 kg/m
- •BMI values should be rounded to the nearest integer.
- •(e.g. 30.4 rounds to 30, while 17.5 rounds to 18).
- •Patient should have established clinical diagnosis based on the following criteria at least 6 months prior to study participation: a.
- •Psoriasis: Confirmed after dermatologic consultation and/or by biopsy.
- •Rheumatoid Arthritis: Based on the ACR 2010 criteria
- •Patient with mild to severe Psoriasis or Rheumatoid Arthritis who are already on established regimen of 2.5 mg every 12 hours (total dose of 7.5mg/week) as 2.5 mg at 12-hour intervals for three doses at least since the last 3 months.
- •No changes expected in Methotrexate (dose and route) in the 4 weeks prior to randomization and the duration of study.
- •Patient on stable dose (≥ 5mg per week) of folic acid or folinic acid supplement for at least 4 weeks prior to randomization and will remain on same stable dose throughout the study as per Principal Investigator or co-Investigator judgment.
- •Patient is willing to provide written informed consent and able to comply with all the study requirements.
- •Patient should be judged eligible by the Principal Investigator or co-Investigator or physician during the screening visit performed within 21 days of the first dose of study medication, which include complete medical history, normal or clinically nonsignificant clinical examination, laboratory tests and other examinations.
排除标准
- •Patient will not be eligible for inclusion in this study if any of the following criteria apply:
- •History of allergic response to Methotrexate or other related drugs or any of its formulation ingredients.
- •History of lymphoproliferative disease or organ allograft.
- •History of cancer (except for in situ cancer, excised or limited stage, curatively treated cancer with no sign of disease for > 5 years).
- •Major surgery of the gastrointestinal tract, the liver or kidney within 4 weeks of study entry (check-in day) which may impact on the pharmacokinetics of Methotrexate.
- •Patient suffering from ascites or pleural effusion.
- •Patient using concomitant medication listed in Prohibited medicines (Refer Section 6.5) if are stable on any of the medication since the last 30 days and in the opinion of Study Investigator and Medical Monitor, it would not affect the study objective, then they can continue the same drug (route and dose) throughout the study period.
- •Note: If the patient was on any of the prohibited medications outlined in Section 6.5, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug and the first dose of study medication.
- •Patient suffering from alcoholic liver disease or chronic liver disease.
- •Patient who have pre-existing blood dyscrasias such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia.
- •Any significant disease or condition which might compromise the haemopoetic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, endocrine, psychosis or any other body system.
- •Patient with a positive test result for Hepatitis (includes subtypes B & C), HIV and/or syphilis (RPR/VDRL).
- •Patient with chest X-ray suggestive of any lung infection including Pulmonary Tuberculosis (TB).
- •History of cardiovascular disease with New York Heart Association (NYHA)3 Functional class II or higher or significant cardiac disease arrhythmias; or history of stroke or uncontrolled hypertension (systolic blood pressure [BP] ≥ 160 mmHg and diastolic BP ≥ 95 mmHg).
- •Patient with following laboratory abnormalities will be excluded: ï‚· Patient on screening total WBC count <3000μL, platelets < 100,000/μL, ANC < 1,500μL or hemoglobin < 8.5g/dL.
- •ï‚· Patient with history of renal trauma, glomerulonephritis, a single kidney or a creatinine level > 1.5x ULN.
- •ï‚· Abnormal liver function tests such as AST, ALT or Alkaline Phosphatase > 2x ULN.
- •Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days prior to drug administration.
- •Ingestion of any alcoholic, caffeine or xanthine containing food or beverage, recreational drugs within 48 hour prior to randomization.
- •Participation in any investigational drug study within 30 days prior to randomization.
- •Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) within 60 days prior to randomization.
- •Patient with a history of drug dependence, history of alcoholism in the past 2 years prior to screening.
- •Patient with a history of allergic response to heparin.
- •Any food allergy, intolerance, restriction or special diet that in the opinion of the Principal Investigator (PI) or Sub-Investigator, could contraindicate the patient’s participation in the study.
- •Any other condition that, in the Investigator’s judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •Employee of the Investigator, CRO, Sponsor who is involved in the study or immediate family members (e.g. partner, offspring, parents, siblings or sibling’s offspring) of an employee who is involved in the study.
结局指标
主要结局
Cmax: Maximum measured plasma
时间窗: 2 Weeks
concentration over the time span specified.
时间窗: 2 Weeks
AUC12: The area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the 12 hours.
时间窗: 2 Weeks
Note: Extrapolation method will be used for calculation of AUC12 wherever applicable.
时间窗: 2 Weeks
次要结局
- Tmax: Time of the maximum measured plasma concentration. If the maximum plasma concentration occurs at more than one time point, the first is chosen as Tmax.(2 Weeks)
研究者
研究点 (5)
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