An Open Label, Balanced, Randomized, Multi-centric, Two-Treatment, Two-Sequence, Two-Period, Single Dose, Crossover bioequivalence Study in adult human patients with Rheumatoid Arthritis (RA) who are on a regimen of oral Azathioprine under fasting condition.
- Conditions
- Health Condition 1: M058- Other rheumatoid arthritis with rheumatoid factor
- Registration Number
- CTRI/2018/08/015374
- Lead Sponsor
- InvaTech Pharma Solutions LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: <br/ ><br>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. <br/ ><br>Secondary objective: <br/ ><br>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.Timepoint: 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 Outcome Measures
Name Time Method Secondary objective: <br/ ><br>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.Timepoint: Medical Examination will be performed at the time of check-in, at the time of last sampling time point of period I and at the time of check-out 24.00 hours post dose of period-II. <br/ ><br>Vital signs (Blood pressure, pulse rate, respiratory rate and body temperature) will be recorded at check in, pre dose in each period and at checkout of period II.