CTRI/2014/11/005175进行中（未招募）未知
An open label, balanced, randomized, multi-centre, two treatment, two sequence, twoperiod, single dose crossover study to evaluate the bioequivalence of Azathioprine 50 mgTablets of Alkem Laboratories Ltd., India compared to Imuran® 50 mg Tablets ofPrometheus Laboratories Inc., USA in adult Rheumatoid Arthritis patients
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 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. Male or female subjects should be 18-65 (both inclusive) years of age at
- •the screening visit.
- •2. RA patients on maintenance therapy with single fixed dose of
- •Azathioprine 50 mg per day with or without a fixed dose (maximum of
- •30 mg/week) of Methotrexate
- •3. Subjects with prior/current use of corticosteroids usage can be enrolled
- •provided they should be on/off for at least 2 weeks prior to enrollment.
- •The maximal daily dose of corticosteroid at Baseline must not exceed
- •the equivalent of 10 mg of prednisone.
- •4. Subjects without clinically significant condition or situation, other than
- •RA that, in the opinion of the investigator, would interfere with the
- •study evaluations or optimal participation in the study.
- •5. Subjects willing and able to adhere to the study assessment schedule and
- •other protocol requirements as evidenced by a written informed consent.
排除标准
- •1.Subject with known low or absent TPMT activity
- •2.Anemia Hemoglobin < 08 gm% (except when principal investigator feels it is secondary to disease activity/MTX induced and in the best judgment of subject who is fit for phlebotomy blood loss as per protocol)
- •3.Subject with inadequate hepatic, renal and bone marrow function
- •Body system Parameters
- •Bone marrow functionANC <= 1500/mm3 and WBC <= 4000/mm3 (should meet both)
- •Platelet count <= 100,000/mm3
- •Renal functionSerum Creatinine >= 2 times ULN
- •Hepatic functionTotal Bilirubin >= 1.5 times ULN
- •ALT/AST >= 2 times ULN
- •Alkaline phosphatase >= 2 times ULN
- •4.Subject with known active/infections like tuberculosis, hepatitis, (e.g. tuberculosis, pneumonia, histoplasmosis) prior to screening which in opinion of PI might get flared up
- •5.Subject with small bowel injury
- •6.Subject with bone marrow suppression (platelets / leucocytes < 1 x lower normal level)
- •7.Pregnancy or expecting pregnancy or lactation within 6 months.
- •8.Subject with history of a known allergy/sensitivity to study drug or its excipients
- •9.Subject with other inflammatory diseases that might interfere with the evaluation of the RA.
- •10.Subject have presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening).
- •11.Subject with any current known malignancy or malignancy within 5 years prior to screening (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •12.Subject participating in any other clinical study or has received treatment with any investigational drug or device within 3 months prior to screening
- •13.Use of any recreational drugs or history of drug addiction.
- •14.Any other condition or abnormal findings that, in the investigatorâ??s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
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