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CTRI Number  CTRI/2021/08/035480 [Registered on: 06/08/2021] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Study of Methotrexate Tablets 2.5 mg in Adult Patients with Mild to Severe Psoriasis or Rheumatoid Arthritis 
Scientific Title of Study   An Open-Label, Randomized, Single-Dose, Two-Period, Two-Treatment, Two-Sequence, Crossover, Multicenter, Bioequivalence Study of Two Formulations of Methotrexate Tablets USP 2.5mg in Patients with Mild to Severe Psoriasis or Rheumatoid Arthritis Under Fasting Conditions. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Protocol No.: C2A00636 Version: 02 Date: 14 Sep 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Domadia 
Designation  Vice President – Global Clinical Operations 
Affiliation  Cliantha Research Limited 
Address  Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev Ahmadabad GUJARAT 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  079-66219555  
Fax  079-66219549  
Email  ddomadia@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankesh Barnwal 
Designation  Associate Director-I Medical Services 
Affiliation  Cliantha Research Limited 
Address  Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev Ahmadabad GUJARAT 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  079-66219545  
Fax  079-66219449  
Email  abarnwal@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Mr Devesh Verma 
Designation  Associate Director  
Affiliation  Cliantha Research Limited 
Address  Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev Ahmadabad GUJARAT 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  079-66219577  
Fax  079-66219549  
Email  dverma@cliantha.com  
 
Source of Monetary or Material Support  
Alembic Pharmaceuticals Limited, Alembic Road, Vadodara - 390 003 Gujarat, India  
 
Primary Sponsor  
Name  Alembic Pharmaceuticals Limited 
Address  Alembic Road, Vadodara - 390 003 Gujarat, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Maheshwari  Amena Khatun Multi Speciality Hospital  OPD Room Number 8: 1st Floor Amena Khatun Multi Speciality Hospital, Opp. Sonal Cinema, Sarkhej Road, Ahmedabad, Gujarat – 380055, India.
Ahmadabad
GUJARAT 		 9898983555

drsunilmaheshwari10@gmail.com 
Dr Hardik Shah  DHS Multispeciality Hospital  Vastrapur lake- Himalaya mall link road, Sunrise park, Vastrapur,
Ahmadabad
GUJARAT 		 9727726933

doc.hardikshah@gmail.com 
Dr Pratik Vinchhi  Parth Orthopedic and Surgical Hospital  OPD: Room No. E/405-4, 407-411, Fourth Floor, Parth Orthopedic and Surgical Hospital, Galaxy Arcade, Near Galaxy Cinema, Naroda. Gujarat – 382330, India
Ahmadabad
GUJARAT 		 9909032354

pratikdevanshzarana@gmail.com 
Dr Indraneel Basu  Shubham Sadbhawana Super Speciality Hospital  3rd Floor OPD: Room No. B3l/80, Shubham Sudbhawana Super speciality Hospital, 23B-Bhogabeer,Lanka Varanasi-221005, Uttar Pradesh, India
Varanasi
UTTAR PRADESH 		 9935036063

dribasumd@yahoo.co.in 
Dr Liyakat Ali Gauri  SP Medical college and AG of Hospitals  OPD: Room No. 1, Ground Floor, Dept of Medicine S.P. Medical College and AG of Hospitals, Bikaner - 334003, Rajasthan, India
Bikaner
RAJASTHAN 		 9829795116

drliyakatgauri@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Amena Khatun Hospital Ethics Committee  Approved 
ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, BIKANER  Approved 
Parth Hospital Ethics Committee  Approved 
Riddhi Medical Nursing Home Institutional Ethics Committee  Approved 
Shubham Sudbhawana Super. Hosp. Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L40||Psoriasis, (2) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Methotrexate  Dose: 2.5 mg; Frequency: day 01 and day 08; route of Administration: oral; Duration of treatment: total 02 days (on day 1st and day 8th) 
Comparator Agent  Methotrexate  Dose: 2.5 mg; Frequency: day 01 and day 08; route of Administration: oral; Duration of treatment: total 02 days (on day 1st and day 8th) 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient will be eligible for inclusion in this study only if all of the
following criteria apply:
1. Male or non-pregnant, non-lactating female between 18-65 years
of age (both inclusive).
a. Male patient if sexually active with a female of child bearing
potential must agree to use barrier method of contraception
throughout the study period and for at least 3 months after last
dose of study drug.
b. Female of childbearing potential must have a negative serum
pregnancy test performed within 21 days prior to initiation of the study & urine pregnancy test at the time of check-in of
each period.
c. Female patient of childbearing potential must use highly
effective methods of contraception throughout the study
period and agree to continue contraception for at least 6
months after the last dose of study drug.
Acceptable forms of contraception include the following:
i. Intrauterine device in place for at least 3 months prior to
the start of the study and remaining in place during the
study period, or
ii. Barrier methods containing or used in conjunction with
a spermicidal agent, or
iii. Surgical sterilization, or
iv. Practice sexual abstinence throughout the course of the
study.
d. Female will not be considered of child bearing potential if one
of the following is reported and documented in the medical
history:
i. spontaneous amenorrhea for at least one year, or
ii. 6 months of spontaneous amenorrhea with serum FSH
levels >40 mIU/mL, or
iii. at least 6 weeks post-surgery following bilateral
oophorectomy with or without hysterectomy.
2. Patient should have a Body Mass Index (BMI) less than or equal
to 30 but greater than or equal to 18 kg/m2. BMI values should
be rounded to the nearest integer. (e.g. 30.4 rounds to 30, while
17.5 rounds to 18).
3. Patient should have established clinical diagnosis based on the
following criteria at least 6 months prior to study participation:
a. Psoriasis: Confirmed after dermatologic consultation and/or
by biopsy.
b. Rheumatoid Arthritis: Based on the ACR 2010 criteria
4. Patient with mild to severe Psoriasis or Rheumatoid Arthritis
who are already on established regimen of 2.5 mg every 12 hours
(total dose of 7.5mg/week) as 2.5 mg at 12-hour intervals for
three doses at least since the last 3 months.
5. No changes expected in Methotrexate (dose and route) in the 4
weeks prior to randomization and the duration of study.
6. Patient on stable dose (≥ 5mg per week) of folic acid or folinic
acid supplement for at least 4 weeks prior to randomization and
will remain on same stable dose throughout the study as per
Principal Investigator or co-Investigator judgment.
7. Patient is willing to provide written informed consent and able to
comply with all the study requirements.
8. Patient should be judged eligible by the Principal Investigator or
co-Investigator or physician during the screening visit performed
within 21 days of the first dose of study medication, which
include complete medical history, normal or clinically nonsignificant
clinical examination, laboratory tests and other
examinations. 
 
ExclusionCriteria 
Details  Patient will not be eligible for inclusion in this study if any of the
following criteria apply:
1. History of allergic response to Methotrexate or other related
drugs or any of its formulation ingredients.
2. History of lymphoproliferative disease or organ allograft.
3. History of cancer (except for in situ cancer, excised or limited
stage, curatively treated cancer with no sign of disease for > 5
years).
4. Major surgery of the gastrointestinal tract, the liver or kidney
within 4 weeks of study entry (check-in day) which may impact
on the pharmacokinetics of Methotrexate.
5. Patient suffering from ascites or pleural effusion.
6. Patient using concomitant medication listed in Prohibited
medicines (Refer Section 6.5) if are stable on any of the
medication since the last 30 days and in the opinion of Study
Investigator and Medical Monitor, it would not affect the study
objective, then they can continue the same drug (route and dose)
throughout the study period.
Note: If the patient was on any of the prohibited medications outlined in
Section 6.5, sufficient wash out period (of at least 5 half-lives) must have
elapsed since the last dose of such drug and the first dose of study
medication.
7. Patient suffering from alcoholic liver disease or chronic liver
disease.
8. Patient who have pre-existing blood dyscrasias such as bone
marrow hypoplasia, leucopenia, thrombocytopenia or significant
anemia.
9. Any significant disease or condition which might compromise
the haemopoetic, gastrointestinal, renal, hepatic, cardiovascular,
respiratory, central nervous system, endocrine, psychosis or any
other body system.
10. Patient with a positive test result for Hepatitis (includes subtypes
B & C), HIV and/or syphilis (RPR/VDRL).
11. Patient with chest X-ray suggestive of any lung infection
including Pulmonary Tuberculosis (TB).
12. History of cardiovascular disease with New York Heart
Association (NYHA)3 Functional class II or higher or significant
cardiac disease arrhythmias; or history of stroke or uncontrolled
hypertension (systolic blood pressure [BP] ≥ 160 mmHg and
diastolic BP ≥ 95 mmHg).
13. Patient with following laboratory abnormalities will be excluded:
 Patient on screening total WBC count <3000μL, platelets <
100,000/μL, ANC < 1,500μL or hemoglobin < 8.5g/dL.
ï‚· Patient with history of renal trauma, glomerulonephritis, a
single kidney or a creatinine level > 1.5x ULN.
ï‚· Abnormal liver function tests such as AST, ALT or Alkaline
Phosphatase > 2x ULN.
14. Consumption of grapefruit, grapefruit-like or grapefruit
containing products within 7 days prior to drug administration.
15. Ingestion of any alcoholic, caffeine or xanthine containing food
or beverage, recreational drugs within 48 hour prior to
randomization.
16. Participation in any investigational drug study within 30 days
prior to randomization.
17. Patient with a history of difficulty in swallowing or any
gastrointestinal disease which could affect drug absorption.
18. Donation or loss of blood or plasma of one unit (about 450 mL
whole blood or 220 mL plasma) within 60 days prior to
randomization.
19. Patient with a history of drug dependence, history of alcoholism
in the past 2 years prior to screening.
20. Patient with a history of difficulty with donating blood or
difficulty in accessibility of veins or intolerance to venipuncture.
21. Patient with a history of allergic response to heparin.
22. Any food allergy, intolerance, restriction or special diet that in
the opinion of the Principal Investigator (PI) or Sub-Investigator,
could contraindicate the patient’s participation in the study.
23. Any other condition that, in the Investigator’s judgment might
increase the risk to the patient or decrease the chance of obtaining
satisfactory data needed to achieve the objectives of the study.
24. Employee of the Investigator, CRO, Sponsor who is involved in
the study or immediate family members (e.g. partner, offspring,
parents, siblings or sibling’s offspring) of an employee who is
involved in the study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cmax: Maximum measured plasma
concentration over the time span specified.

AUC12: The area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the 12 hours.

Note: Extrapolation method will be used for calculation of AUC12 wherever applicable.
 		 2 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax: Time of the maximum measured plasma concentration. If the maximum plasma concentration occurs at more than one time point, the first is chosen as Tmax.  2 Weeks 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 01/11/2021 
Date of Study Completion (India) 15/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/12/2021 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is an open-label, randomized, single-dose, two-period, two treatment, two-sequence, crossover, multicenter bioequivalence study in patients with mild to severe psoriasis or rheumatoid arthritis under fasting condition.

 
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