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CTRI Number  CTRI/2016/01/006508 [Registered on: 11/01/2016] Trial Registered Prospectively
Last Modified On: 30/01/2016
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Clinical Trial to study the clinical bioequivalence of of Methotrexate Tablets USP 2.5 mg (Test) of Eugia Pharma Specialities Limited, India with Methotrexate Tablets USP 2.5 mg (Reference) of Dava Pharmaceuticals Inc USA in patients with mild to severe Psoriasis or Rheumatoid arthritis  
Scientific Title of Study   A multicenter open label randomized two treatment two sequence two period crossover oral bioequivalence study of methotrexate tablets USP 2.5 mg ( Test) of Eugia Pharma Specialities Limited India ( A joint venture of Aurobindo Pharma Limited and Celon Laboratories Limited) and methotrexate table USP 2.5 mg ( reference) of Dava Pharmaceuticals Inc USA in adult patients with mild to severe psoriasis or rheumatoid arthritis who are already on established regimens of 2.5 mg every 12 hours under fasting condition 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President  
Affiliation  AXIS Clinicals Limited  
Address  1-121/1 Miyapur Hyderabad

Hyderabad
ANDHRA PRADESH
500049
India 
Phone  04040408064  
Fax  04040408003  
Email  subhra.l@axisclinicals.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President  
Affiliation  AXIS Clinicals Limited  
Address  1-121/1 Miyapur Hyderabad

Hyderabad
ANDHRA PRADESH
500049
India 
Phone  04040408064  
Fax  04040408003  
Email  subhra.l@axisclinicals.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President  
Affiliation  AXIS Clinicals Limited  
Address  1-121/1 Miyapur Hyderabad

Hyderabad
ANDHRA PRADESH
500049
India 
Phone  04040408064  
Fax  04040408003  
Email  subhra.l@axisclinicals.com  
 
Source of Monetary or Material Support  
Eugia Pharma Specialties  
 
Primary Sponsor  
Name  Eugia Pharma Specialities Limited A JV of Aurobindo Pharma Limited and Celon Laboratories Limited 
Address  Sy No 550 551 and 552 Kolthur (Village) Shameerpet (Mandal) RR District TS India 500078 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
AXIS Clinicals Limited   1-121/1 Miyapur Hyderabad - 500049 India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajit Nalawade  Inamdar Multispeciality Hospital  Hospital Building S No-15 Fathima Nagar 411040
Pune
MAHARASHTRA 		 02030502244

dr.ajitnalawade@gmail.com 
Dr Laxmikant Goyal  Malpani Multispeciality Hospital  SP-6 Road No 1 VKI Area Sikar Road 302013
Jaipur
RAJASTHAN 		 9462651019

kgoyal@gmail.com 
Dr Shailaja Bhatia  Medipoint Hospital  241/1 New DP Road Aundh 411007Baner Boundry Baner Road
Pune
MAHARASHTRA 		 02027298081
02039841300
shailajagbhatia@gmail.com 
Dr Nilesh Patil  Nobel Hospital  153 Magarpatta City Road Hadapsar 411013
Pune
MAHARASHTRA 		 9673100066
02066285199
nspatil@gmail.com 
Dr Gaurav Rathi   Rathi Hospital  Near Anupam Shopping Centre Opp Mahabaleshwar Society Near Jodhpur Cross Road Satellite 380015
Ahmadabad
GUJARAT 		 0792694841
07926924812
drgjrathi@yahoo.co.in 
Dr Jigar Parikh  Ratnadeep Multispeciality Hospital  2nd Floor Nakshatra Coplex Above HDFC Bank Maninagar Cross Road Maninagar 380008
Ahmadabad
GUJARAT 		 07925465119
07922124022
ramyaclinic_306@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee Inamdar Multispeciality Hospital  Approved 
Ethics Committee Ratnadeep Multispeciality Hospital  Approved 
Institutional Ethics Committee Malpani Multispeciality Hospital  Approved 
Institutional Ethics Committee Nobel Hospital  Approved 
Pentamed Ehics Committee  Approved 
Rathi Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  1.Mild to Severe Psoriasis 2.Rheumatoid Arthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Methotrexate Tablet (USP) 2.5mg   One 2.5 mg tablet every 12 hours interval (total 7.5mg per week) orally and total duration of therapy is 9 days 
Comparator Agent  Methotrexate Tablet USP 2.5mg   One 2.5 mg tablet every 12 hours interval ( Total 7.5mg per week) orally and total duration of therapy is 9days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
2. Subject aged between 18 to 65 years and of either sex and any race and should have BMI ≥ 18.5 to ≤ 30 kg/m2
3. Diagnosed Subjects with mild to severe psoriasis (has involved body surface area (BSA) ≥ 10 % and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline)
or
Rheumatoid Arthritis (RA) diagnosed according to the 2010 ACR/EULAR classification criteria (mentioned in appendix 3).
4. Patient with mild to severe Psoriasis or Rheumatoid Arthritis who are receiving Methotrexate 2.5 mg orally every 12 hours for 3 doses (i.e. A total dose of 7.5 mg/week).
5. Subjects agreed to use acceptable methods of birth control as directed by study team.
6. Female subjects of childbearing potential must have a negative pregnancy test at Screening.
7. Subjects having adequate hematologic reserve at screening as per principal investigator/sub investigator assessment.
8. Subjects having adequate and stable hepatic function and renal function at screening as per principal investigator/sub investigator assessment.
9. Patients should be otherwise healthy as determined by physical examination, medical history and no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
10. Patient must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures. 
 
ExclusionCriteria 
Details  1.A female subject, who is pregnant, intends to become pregnant during the study (or within 6 months after study completion) or breast feeding.
2. Patient with fibromyalgia syndrome.
3. Treatment with any investigational drug within 3 months prior to screening.
4. History of infected joint prosthesis within the previous 5 years.
5. Patient with chronic infections like Pneumocystis carinii pneumonia.
6. History of receiving radiotherapy treatment.
7. History or evidence of hypersensitivity to Methotrexate or to Misoprostol or other prostaglandins and its ingredients.
8. History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection.
9. Patient with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
10. Patient diagnosed to be HIV 1 and 2 or Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
11. Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.
12. History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
13. Subject is part of the staff or a family member of the staff personnel directly involved with this study.
14. History of drug abuse.
15. Patient with history of tumor lysis syndrome.
16. History of difficulty with donating blood or difficulty in swallowing thedrug or difficulty in accessibility of veins.
17. Patient is under any treatment which could affect the pharmacokinetic of Methotrexate (Salicylates, Hypoglycaemics, Diuretics, Sulphonamides, Diphenylhydantoins, Tetracyclines, Chloramphenicol and P-aminobenzoic acid, Probenecid, Pencillins, chloroquine, Omeprazole, Etretinate, Co-trimoxazole and Trimethoprim etc.,) administered in past 1 month.
18. Patient is taking prescription of medications listed below:
Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin, Leflunomide, Hydroxychloroquine, Cyclosporin or Anti-tumor necrosis factor therapies within 90 days of visit 1 or treatment with Rituximab within 1 year before Visit 1.
19. High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
20. Patient donated blood ≥ 350 mL within 90 days of screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary AUC0-12: The area under the plasma concentration versus time curve, from time 0 to 12 hours, as calculated by the linear trapezoidal method. Cmax: Maximum measured plasma concentration over the time span specified.  Day 1 and 8 at 0.00 , 0.25, 0.50, 0.75, 1.00, 1.25. 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00 and 12 hours post dose 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax: Time of the maximum measured plasma concentration. Kel: Apparent first order elimination rate constant calculated from a semi-log plot of plasma concentration versus time point. T½: The elimination or terminal half-life will be calculated as 0.693 /Kel. Safety and tolerability as assessed by reported adverse events (laboratory and clinical investigations and vital signs)  Day 1 and 8 at 0.00 , 0.25, 0.50, 0.75, 1.00, 1.25. 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00 and 12 hours post dose 
 
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)   13/01/2016 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a multicentre study of Methotrexate 2.5mg tablet for the assessment of Clinical Bio-equivalence as per PK analysis. This is an open label , randomized , two treatment , two sequence , two period crossover oral bioequivalence study of Methotrexate 2.5mg (test) of Eugia Pharma Specialities Limited , India ( A Joint Venture of Aurobindo Pharma Limited & Celon Laboratories Limited) with Methotrexate Tablet USP 2.5mg (Reference of Dava Pharmaceuticals Inc ., USA ) in adult patient with mild to severe psoriasis or Rheumatoid Arthritis in patients who are already on established regimens of 2.5mg every 12 hours under fasting condition . 
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