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.

InvaTech Pharma Solutions LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Adult patients with Rheumatoid Arthritis (RA) aged between 18 to 65 years, both inclusive, at the first time of signing of the informed consent.
•2. Completed the screening process within 21 days prior to Period I dosing.
•3. Body mass index (BMI) between 18.5 kg/m2 to 29.9 kg/m2 and weigh at least 50 kg.
•4. RA patients on maintenance therapy, who are already receiving Azathioprine at a fixed dose of 50 mg/day.
•5. 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.
•6. RA factor done within 6 months of screening or at screening suggestive of active Rheumatoid arthritis.

•1. Patients with inherited deficiency of Thiopurine methyltransferase (TPMT) activity (less than 5.5 unit).
•2. Patients with concomitant chemotherapy.
•3. Patients with prior exposure to doxorubicin
•4. 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).
•5. Subject with inadequate hepatic, renal and bone marrow function
•6. 6. Reports of any history of malignancy including post-transplant lymphoma and hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease.
•7. 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.

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