Health Condition 1: null- Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Azathioprine Tablets: Manufactured by Alkem Laboratories Ltd. India
(Strength 50mg, single dose, orally)
Control Intervention1: Imuran (azathioprine) Tablets: Manufactured by Prometheus
Sponsors
Alkem Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Subject with known low or absent TPMT activity 2. Anemia Hemoglobin 3. Subject with inadequate hepatic, renal and bone marrow function Body system Parameters Bone marrow function ANC Platelet count Renal function Serum Creatinine >= 2 times ULN Hepatic function Total 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 the Test product and Reference product.Timepoint: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Azathioprine 50 mg Tablets following single dose under fasting conditionTimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Mujtaba Naqvi
ClinSync Clinical Research Pvt Ltd.
Outcome results
None listed