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CTRI Number  CTRI/2018/08/015374 [Registered on: 17/08/2018] Trial Registered Prospectively
Last Modified On: 24/09/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   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. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PCLPL-008-16 Version.: 02 Date: 03/04/18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simran Sethi 
Designation  Head-Clinical Trials 
Affiliation   
Address  R 374 MIDC TTC Industrial area Rabale Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400701
India 
Phone  9825784942  
Fax    
Email  simran@panexcell.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simran Sethi 
Designation  Head Clinical Trials 
Affiliation  Panexcell Clinical Lab Pvt. Ltd. 
Address  R 374 MIDC TTC Industrial area Rabale Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400701
India 
Phone  02239697979  
Fax  02239697980  
Email  simran@panexcell.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Sethi 
Designation  Head Clinical Operations 
Affiliation  Panexcell Clinical Lab Pvt. Ltd. 
Address  R 374 MIDC TTC Industrial area Rabale Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
400701
India 
Phone    
Fax    
Email  simran@panexcell.com  
 
Source of Monetary or Material Support  
InvaTech Pharma Solutions LLC 40 C Cotters Lane, Suite # A East Brunswick, NJ 08816 
 
Primary Sponsor  
Name  InvaTech Pharma Solutions LLC 
Address  40 C Cotters Lane, Suite # A East Brunswick, NJ 08816 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karnav Arvindbhai Panchal  Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre  Department of Orthopedics “Ratubhai Adani Arogyadham”, Ayojannagar, Nr. Shreyas crossing road, Dr. Jivraj Mehta Marg, Paldi Ahmedabad – 380007
Ahmadabad
GUJARAT 		 9879010009

karnav1985@yahoo.com 
Dr Rohit Deshpande  Grant Govt Medical College   Sir J J Hospital Compound Byculla Mumbai
Mumbai
MAHARASHTRA 		 9096050150

coolrohit258@gmail.com 
Dr Smruti Ramteke  Meditrina Institute of Medical Sciences  278 Central Bazar Road Ramdaspeth Nagpur Maharashtra 440012
Nagpur
MAHARASHTRA 		 9823514680

sramteke@rediffmail.com 
Dr Gaurav Rathi  Rathi Hospital   Near Anupam Shopping Centre Opposite Mahabaleshwar Society Jodhpur Cross Roads Ahmedabad 380015
Ahmadabad
GUJARAT 		 9824015618

drgjrathi@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre Institutional Ethics Committee  Approved 
Ethics Committee Meditrina Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee Grant Govt Medical College  Submittted/Under Review 
Rathi Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference Product (R) IMURAN (Azathioprine) 50 mg Tablets  Prometheus Laboratories Inc., US Dose:50 mg tablet Frequency: Once per day Route of Administration: Oral 
Intervention  Test Product (T) Azathioprine 50 mg Tablets   Manufactured for InvaTech Pharma Solutions LLC, US, manufactured by Elysium Pharmaceuticals Ltd., Vadodara, India 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Objective:
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.
Secondary objective:
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. 		 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  
Outcome  TimePoints 
Secondary objective:
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. 		 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.
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.  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   01/09/2018 
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="6"
Days="0" 
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  
Study Title
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.
Objective
Primary Objective:
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.
Secondary objective:
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.
Dosing Regimen
In each period, 1 × 50 mg of either test product (T) or reference Product (R) will be administered with 240 ± 5 mL of water under fasting condition (at least 10 hours prior to drug administration).
The time of study drug administration on day 1 will be the reference time for day 2.
The test and reference products will be administered at approximately the same time in each period for each individual subject.
 
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