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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- To characterize the pharmacokinetic profiles of
研究概览
简要总结
It is a BA/BE study to compare the test & reference products of Azathioprine in patients with Rheumatoid Arthritis.
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
- •Male or female subjects should be 18-65 (both inclusive) years of age at the screening visit.
- •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
- •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.
- •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.
- •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 investigator’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.
结局指标
主要结局
To characterize the pharmacokinetic profiles of
时间窗: Blood samples will be collected at Pre-dose (0.00) , 0.16, 0.33, | 0.5, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 hours post-dose in | each period.
Azathioprine and 6-Mercaptopurine following a single dose of Azathioprine
时间窗: Blood samples will be collected at Pre-dose (0.00) , 0.16, 0.33, | 0.5, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 hours post-dose in | each period.
product.
时间窗: Blood samples will be collected at Pre-dose (0.00) , 0.16, 0.33, | 0.5, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 hours post-dose in | each period.
50 mg Tablets under fasting condition and to assess the bioequivalence of
时间窗: Blood samples will be collected at Pre-dose (0.00) , 0.16, 0.33, | 0.5, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 hours post-dose in | each period.
Azathioprine 50 mg Tablets between the Test product and Reference
时间窗: Blood samples will be collected at Pre-dose (0.00) , 0.16, 0.33, | 0.5, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 hours post-dose in | each period.
次要结局
- To assess the safety and tolerability of Azathioprine(50 mg Tablets following single dose under fasting condition)