Bioequivalence study of Azathioprine to measure the pharmacokinetic profiles, safety and tolerability of Test product when compared to the reference product.
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2014/11/005175
- Lead Sponsor
- Alkem Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 40
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.
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 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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetic profiles of <br/ ><br>Azathioprine and 6-Mercaptopurine following a single dose of Azathioprine <br/ ><br>50 mg Tablets under fasting condition and to assess the bioequivalence of <br/ ><br>Azathioprine 50 mg Tablets between the Test product and Reference <br/ ><br>product.Timepoint: Blood samples will be collected at Pre-dose (0.00) , 0.16, 0.33, <br/ ><br>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 <br/ ><br>each period.
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of Azathioprine <br/ ><br>50 mg Tablets following single dose under fasting conditionTimepoint: N/A