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CTRI Number  CTRI/2014/11/005175 [Registered on: 05/11/2014] Trial Registered Prospectively
Last Modified On: 26/02/2015
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Azathioprine to measure the pharmacokinetic profiles, safety and tolerability of Test product when compared to the reference product. 
Scientific Title of Study   An open label, balanced, randomized, multi-centre, two treatment, two sequence, two period, single dose crossover study to evaluate the bioequivalence of Azathioprine 50 mg Tablets of Alkem Laboratories Ltd., India compared to Imuran® 50 mg Tablets of Prometheus Laboratories Inc., USA in adult Rheumatoid Arthritis patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C-ALK-AZA-001, version 00, 08-Nov-2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarvajeet Pal 
Designation  Principal Investigator 
Affiliation  Sumana Hospital 
Address  Plot No. 687 & 688 Vivekananda Nagar colony, Near More Super Market, Kukatpally, Hyderabad

Hyderabad
ANDHRA PRADESH
500072
India 
Phone    
Fax    
Email  sumanaresearchunit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mujtaba Naqvi 
Designation  Medical Monitor 
Affiliation  ClinSync Clinical Research Pvt Ltd. 
Address  #4-1-1, Santoshi Maa Complex, Hayathnagar,

Hyderabad
ANDHRA PRADESH
501505
India 
Phone    
Fax    
Email  mujtaba.naqvi@clinsynccro.com  
 
Details of Contact Person
Public Query  
Name  Dr Mujtaba Naqvi 
Designation  Medical Monitor 
Affiliation  ClinSync Clinical Research Pvt Ltd. 
Address  #4-1-1, Santoshi Maa Complex, Hayathnagar,

Hyderabad
ANDHRA PRADESH
501505
India 
Phone    
Fax    
Email  mujtaba.naqvi@clinsynccro.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Ltd., C-17/7, MIDC Industrial Estate, Taloja, Near Dena Bank, Opposite Taloja Police station, Dist. Raigad – 410 208, Maharashtra, India 
 
Primary Sponsor  
Name  Alkem Laboratories Ltd 
Address  C-17/7, MIDC Industrial Estate, Taloja, Near Dena Bank, Opposite Taloja Police station, Dist. Raigad – 410 208, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gururaj Pramod  BIBI General Hospital and Cancer Centre  16-3-991/1/C, Govt. Printing Press Road, Malakpet, Hyderabad - 500024, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH 		 9908649700

drkgururaj@gmail.com 
Dr M Pardha Saradhi  Dept. of Orthopedics,King George Hospital  Dept. of Orthopaedics, King George Hospital, Visakhapatnam-530002, AP
Visakhapatnam
ANDHRA PRADESH 		 9440608752

amcorthopaedics@hotmail.com 
DrDinesh Ramesh Kabre  Kabre Orthopaedic Spine & Dental Centre  Plot No. SEI 4/1, D II Block, Telco Road, Near KSB Pump, MIDC, Chinchwad, Pune-411019
Pune
MAHARASHTRA 		 9325432521

drkabre@rediffmail.com 
Dr T Sudheer  Rajiv Gandhi Institute of Medical Sciences and RIMS Govt. General Hospital  Dept. of Orthopaedics, Srikakulam-532001, AP
Srikakulam
ANDHRA PRADESH 		 9949900369

rimsresearch@gmail.com 
DrGaurav Rathi  Rathi Hospital  Nr. Anupam shopping centre, Opp Mahabaleshwar Soc, Jodhpur Cross Roads, Satellite, Ahmedabad- 380015, Ahmedabad, India.
Ahmadabad
GUJARAT 		 9824015618

drgjrathi@yahoo.co.in 
Dr Sarvajeet Pal  Sumana Hospital  Plot No. 687 & 688 Vivekananda Nagar colony, Near More Super Market, Kukatpally, Hyderabad – 500072
Hyderabad
ANDHRA PRADESH 		 9848091533

sumanaresearchunit@gmail.com 
Dr Bharat Suman Mody  Welcare Hospital  Welcare Hospital, Near Miles Motors, Atladara – Vadsar Road, Atladara, Vadodara-390 012, Gujarat, India.
Vadodara
GUJARAT 		 9824036065
91-265-6623670
centreforkneesurgery@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Bibi Institutional Ethics Committee  Approved 
Ethics Committee of Centre for Knee Surger  Approved 
Institutional Ethics Committee   Approved 
Institutional Ethics Committee   Approved 
Sumana Hospital Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Rheumatoid Arthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Azathioprine Tablets  Manufactured by Alkem Laboratories Ltd. India (Strength 50mg, single dose, orally) 
Comparator Agent  Imuran (azathioprine) Tablets  Manufactured by Prometheus Laboratories Inc., USA (Strength 50mg, single dose, orally) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 function ANC ≤ 1500/mm3 and WBC ≤ 4000/mm3 (should meet both)
Platelet count ≤ 100,000/mm3
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 < 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 investigator’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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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. 		 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 Outcome  
Outcome  TimePoints 
To assess the safety and tolerability of Azathioprine
50 mg Tablets following single dose under fasting condition 		 N/A 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 23/12/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   It is a BA/BE study to compare the test & reference products of Azathioprine in patients with Rheumatoid Arthritis. 
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