An open label, balanced, randomized, multi-centric, single-dose, two-treatment, two- sequence, two period, crossover, bioequivalence study of Azathioprine 50 mg Tablets manufactured for InvaTech Pharma Solutions LLC, US, manufactured by Elysium Pharmaceuticals Ltd., Vadodara, India, with IMURAN (Azathioprine) 50 mg Tablets of Prometheus Laboratories Inc., US, in adult human patients with Rheumatoid Arthritis (RA) who are on a regimen of oral Azathioprine under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- To characterize the pharmacokinetic profiles of Azathioprine and 6-Mercaptopurine following a single dose of Azathioprine 50 mg Tablets under fasting condition and to assess the bioequivalence of Azathioprine 50 mg Tablets between test and reference products.
研究概览
简要总结
Study Title
An open label, balanced, randomized, multi-centric, single-dose, two-treatment, two- sequence, two period, crossover, bioequivalence study of Azathioprine 50 mg Tablets manufactured for InvaTech Pharma Solutions LLC, US, manufactured by Elysium Pharmaceuticals Ltd., Vadodara, India, with IMURAN (Azathioprine) 50 mg Tablets of Prometheus Laboratories Inc., US, in adult human patients with Rheumatoid Arthritis (RA) who are on a regimen of oral Azathioprine under fasting condition.
Objective
Primary Objective:
To characterize the pharmacokinetic profiles of Azathioprine and 6-Mercaptopurine following a single dose of Azathioprine 50 mg Tablets under fasting condition and to assess the bioequivalence of Azathioprine 50 mg Tablets between test and reference products.
Secondary objective:
To assess the safety and tolerability of the test and reference products in adult human patients with Rheumatoid Arthritis (RA) who are on a regimen of oral Azathioprine under fasting condition.
Dosing Regimen
In each period, 1 × 50 mg of either test product (T) or reference Product (R) will be administered with 240 ± 5 mL of water under fasting condition (at least 10 hours prior to drug administration).
The time of study drug administration on day 1 will be the reference time for day 2.
The test and reference products will be administered at approximately the same time in each period for each individual subject.
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
- •Adult patients with Rheumatoid Arthritis (RA) aged between 18 to 65 years, both inclusive, at the first time of signing of the informed consent.
- •Completed the screening process within 21 days prior to Period I dosing.
- •Body mass index (BMI) between 18.5 kg/m2 to 29.9 kg/m2 and weigh at least 50 kg.
- •RA patients on maintenance therapy, who are already receiving Azathioprine at a fixed dose of 50 mg/day.
- •Subjects with prior/current use of corticosteroids usage can be enrolled provided they should be on/off for at least 2 weeks prior to enrolment.
- •The maximal daily dose of corticosteroid at Baseline must not exceed the equivalent of 10 mg of prednisone.
排除标准
- •Patients with inherited deficiency of Thiopurine methyltransferase (TPMT) activity (less than 5.5 unit).
- •Patients with concomitant chemotherapy.
- •Patients with prior exposure to doxorubicin
- •Anemia Hemoglobin < 8.0 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).
- •Subject with inadequate hepatic, renal and bone marrow function
- •Reports of any history of malignancy including post-transplant lymphoma and hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease.
- •Patients who have received the prescription medication (except treatment regimen of azathioprine (including any concomitant therapy) which they are already receiving) 28 days prior to receiving first dose of study medication and throughout the blood collection period.
结局指标
主要结局
To characterize the pharmacokinetic profiles of Azathioprine and 6-Mercaptopurine following a single dose of Azathioprine 50 mg Tablets under fasting condition and to assess the bioequivalence of Azathioprine 50 mg Tablets between test and reference products.
时间窗: 0.00 and post dose administration at 0.16 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00 (60 min), 1.16 (1 hour and 10 min), 1.33 (1 hour and 20 min), 1.67 (1 hour and 40 min), 1.83 (1 hour and 50 min), 2.00 (120 min), 2.33 (2 hour and 20 min), 2.67 (2 hour and 40 min), 3.00 (180 min), 4.00, 5.00, 6.00 and 8.00 hours post dose in each period.
Secondary objective:
时间窗: 0.00 and post dose administration at 0.16 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00 (60 min), 1.16 (1 hour and 10 min), 1.33 (1 hour and 20 min), 1.67 (1 hour and 40 min), 1.83 (1 hour and 50 min), 2.00 (120 min), 2.33 (2 hour and 20 min), 2.67 (2 hour and 40 min), 3.00 (180 min), 4.00, 5.00, 6.00 and 8.00 hours post dose in each period.
Primary Objective:
时间窗: 0.00 and post dose administration at 0.16 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00 (60 min), 1.16 (1 hour and 10 min), 1.33 (1 hour and 20 min), 1.67 (1 hour and 40 min), 1.83 (1 hour and 50 min), 2.00 (120 min), 2.33 (2 hour and 20 min), 2.67 (2 hour and 40 min), 3.00 (180 min), 4.00, 5.00, 6.00 and 8.00 hours post dose in each period.
To assess the safety and tolerability of the test and reference products in adult human patients with Rheumatoid Arthritis (RA) who are on a regimen of oral Azathioprine under fasting condition.
时间窗: 0.00 and post dose administration at 0.16 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00 (60 min), 1.16 (1 hour and 10 min), 1.33 (1 hour and 20 min), 1.67 (1 hour and 40 min), 1.83 (1 hour and 50 min), 2.00 (120 min), 2.33 (2 hour and 20 min), 2.67 (2 hour and 40 min), 3.00 (180 min), 4.00, 5.00, 6.00 and 8.00 hours post dose in each period.
次要结局
- Secondary objective:(To assess the safety and tolerability of the test and reference products in adult human patients with Rheumatoid Arthritis (RA) who are on a regimen of oral Azathioprine under fasting condition.)