CTRI/2021/08/035480已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 48
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
- •Patient will be eligible for inclusion in this study only if all of the
- •following criteria apply:
- •1. Male or non-pregnant, non-lactating female between 18-65 years
- •of age (both inclusive).
- •a. 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.
- •b. 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.
- •c. 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
- •d. Female will not be considered of child bearing potential if one
- •of the following is reported and documented in the medical
- •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.
- •2. Patient should have a Body Mass Index (BMI) less than or equal
- •to 30 but greater than or equal to 18 kg/m2. BMI values should
- •be rounded to the nearest integer. (e.g. 30.4 rounds to 30, while
- •17.5 rounds to 18).
- •3. 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
- •b. Rheumatoid Arthritis: Based on the ACR 2010 criteria
- •4. 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.
- •5. No changes expected in Methotrexate (dose and route) in the 4
- •weeks prior to randomization and the duration of study.
- •6. Patient on stable dose (ââ?°Â¥ 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.
- •7. Patient is willing to provide written informed consent and able to
- •comply with all the study requirements.
- 另有 5 项未显示
排除标准
- •Patient will not be eligible for inclusion in this study if any of the
- •following criteria apply:
- •1. History of allergic response to Methotrexate or other related
- •drugs or any of its formulation ingredients.
- •2. History of lymphoproliferative disease or organ allograft.
- •3. History of cancer (except for in situ cancer, excised or limited
- •stage, curatively treated cancer with no sign of disease for > 5
- •4. 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.
- •5. Patient suffering from ascites or pleural effusion.
- •6. 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.
- •7. Patient suffering from alcoholic liver disease or chronic liver
- •8. Patient who have pre-existing blood dyscrasias such as bone
- •marrow hypoplasia, leucopenia, thrombocytopenia or significant
- •9. 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.
- •10. Patient with a positive test result for Hepatitis (includes subtypes
- •B & C), HIV and/or syphilis (RPR/VDRL).
- •11. Patient with chest X-ray suggestive of any lung infection
- •including Pulmonary Tuberculosis (TB).
- •12. 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] ââ?°Â¥ 160 mmHg and
- •diastolic BP ââ?°Â¥ 95 mmHg).
- •13. Patient with following laboratory abnormalities will be excluded:
- •Ã¯â??· Patient on screening total WBC count <3000Ã?¼L, platelets <
- •100,000/Ã?¼L, ANC < 1,500Ã?¼L or hemoglobin < 8.5g/dL.
- •Ã¯â??· Patient with history of renal trauma, glomerulonephritis, a
- •single kidney or a creatinine level > 1.5x ULN.
- •Ã¯â??· Abnormal liver function tests such as AST, ALT or Alkaline
- •Phosphatase > 2x ULN.
- •14. Consumption of grapefruit, grapefruit-like or grapefruit
- •containing products within 7 days prior to drug administration.
- •15. Ingestion of any alcoholic, caffeine or xanthine containing food
- •or beverage, recreational drugs within 48 hour prior to
- •randomization.
- •16. Participation in any investigational drug study within 30 days
- 另有 4 项未显示
研究者
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