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CTRI Number  CTRI/2022/07/043974 [Registered on: 13/07/2022] Trial Registered Prospectively
Last Modified On: 08/07/2022
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence Study of Tofacitinib 11 mg Extended Release Tablets in a fasting condition  
Scientific Title of Study   A randomized, open label, balanced, two treatment, two period, two sequence, two way crossover, single oral dose, bioequivalence study of Tofacitinib 11mg XR extended-release tablets of Optimus Pharma Pvt. Ltd, India with XELJANZ® XR (Tofacitinib) 11 mg extended-release tablets marketed by Pfizer Labs Division of Pfizer Inc. NY. NY10017 in healthy adult human subjects under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BIOS/2022/053 Version No.01, Date:17.02.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr harminder Dua 
Designation  Principal Investigator 
Affiliation  Bio Scientific Research Laboratories (I) Pvt. Ltd. 
Address  BIOS HOUSE, Plot No. 106 3, Aries Compound, Opp. Thakur Mall, SV Road, Mira Road, Thane

Thane
MAHARASHTRA
401104
India 
Phone    
Fax    
Email  h.dua@biosrl.com  
 
Details of Contact Person
Scientific Query  
Name  Dr harminder Dua 
Designation  Principal Investigator 
Affiliation  Bio Scientific Research Laboratories (I) Pvt. Ltd. 
Address  BIOS HOUSE, Plot No. 106 3, Aries Compound, Opp. Thakur Mall, SV Road, Mira Road, Thane

Thane
MAHARASHTRA
401104
India 
Phone    
Fax    
Email  h.dua@biosrl.com  
 
Details of Contact Person
Public Query  
Name  Vinayak Sargar 
Designation  Assistant Manager- Medical Affairs 
Affiliation  Optimus Pharma Pvt. Ltd.  
Address  Optimus Pharma Pvt. Ltd. 2nd Floor, Signature Towers, Kothaguda Kondapur,

Hyderabad
TELANGANA
500084
India 
Phone    
Fax    
Email  vinayak@optimuspharma.com  
 
Source of Monetary or Material Support  
Optimus Pharma Pvt Ltd 
 
Primary Sponsor  
Name  Optimus Pharma Pvt Ltd 
Address  2nd Floor, Signature Towers, Kothaguda Kondapur, Telangana 500084, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harminder Dua  Bio Scientific Research Laboratories (I) Pvt. Ltd.  BIOS HOUSE, Plot No. 106 3, Aries Compound, Opp. Thakur Mall, SV Road, Mira Road, Thane
Thane
MAHARASHTRA 		 2228963582

h.dua@biosrl.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksha Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult human subjects within 18-45 years of age (both inclusive). 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tofacitinib 11mg XR extended release tablets  Manufactured by Optimus Pharma Pvt. Ltd 
Comparator Agent  XELJANZ® XR (Tofacitinib) 11 mg extended-release tablets  Marketed by Pfizer Labs Division of Pfizer Inc.NY. NY10017 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects to be enrolled in the study have to meet all of the following criteria:
1. Subjects willing to give Informed Consent.
2. Healthy adult human subjects within 18-45 years of age (both inclusive).
3. Body Mass Index (BMI) having range between 18.5 and 30.0 kg/m2 (both inclusive).
4. Willingness to follow protocol requirements as per the subject information sheet.
5. Subjects who have no evidence of underlying disease (including serious infections) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
6. Subjects whose screening laboratory values and X ray Chest are within normal limits or considered by the Physician / Principal Investigator / Co-Investigator to be of no clinical significance.
7. Subjects should have normal liver function tests, blood counts, and lipid profiles at baseline prior to study drug administration.
8. Physical examination and vital sign examination of the subject conducted on the day of
screening and check-in are within acceptable limits.
9. Subjects who agree to abstain from consuming any xanthine / caffeine containing food or
beverages (chocolates, tea, coffee or soft drinks), grapefruit juice and products, alcoholic
products, cigarettes and tobacco products for at least 48.00 hours prior to dosing and
throughout the study period until the last blood sample is being obtained.
10. Subjects should be tested and confirmed negative for latent tuberculosis before enrolling in a bioequivalence study.
11. Subjects should have normal liver function tests, normal renal function tests, blood counts, and lipid profiles at baseline prior to study drug administration.
12. Volunteers willing to use most effective barrier contraceptive methods during and for 07 days after the end of treatment. In addition, volunteers will be instructed not to have sexual intercourse with pregnant woman during this period.
13. For female subjects:
 Negative urine pregnancy test during screening and negative serum β-hCG test at the time check-in of each study period;
ï‚· Female subjects with child bearing potential or those within their first two years of on-set of menopause, willing to either abstain from sexual intercourse or use of acceptable birth control methods for at least 15 days before 1st check-in till 15 days post last-dose / entire study period. [Acceptable birth control methods includes barrier methods such as diaphragm/ condom with or without spermicide or surgically sterile (bilateral tubal liga-tion, bilateral oophorectomy or hysterectomy has been performed)]. 
 
ExclusionCriteria 
Details  Subjects will be excluded for ANY ONE of the following reasons:
1. History of allergy or hypersensitivity or intolerance to Tofacitinib or related class of drugs or its formulation excipients which, in the opinion of a clinical investigator, would com-promise the safety of the subject or the study;
2. Significant medical disorder (cardiovascular, gastrointestinal, renal, pulmonary, haemato-logical, endocrine, or metabolic disorder (e.g. diabetes mellitus), malignancy, or immuno-deficiency disorder, hepatic and neurological or psychiatric) as determined by history.
3. Subjects with evidence of underlying disease (including serious infections) during screening medical history
4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs etc.
5. Significant abnormal finding as determined by clinical examination including 12-lead ECG, X ray Chest and vital signs.
6. Any major illness or hospitalized within 90 days prior to the first check-in; Use of any rec-reational drug or history of drug addiction.
7. History of difficulty in accessibility of veins in arms and difficulty in withdrawing the blood.
8. Difficulty in swallowing the oral medication.
9. Found positive in urine alcohol test done before check-in and ambulatory samples for each study period.
10. Found positive in urine test for drugs of abuse done before check-in for each study period.
11. Depot injections or implants within 6 months.
12. Positive screening test for any one: HIV, hepatitis B, hepatitis C and VDRL.
13. Consumption of xanthine / caffeine containing products, tobacco containing products, grapefruit juice and products and alcohol within 48.00 hours prior to dosing.
14. Refusal to abstain from food for at least 10.00 hours prior to study drug administration and until at least 04.00 hours post-dose, in each study period.
15. Refusal to abstain from consumption of tobacco products 48.00 hours prior to dosing until the last blood sample collection of last study period.
16. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration until at least 01.00 hour post-dose, in each study period except 240 ± 02 mL of drinking water.
17. Requirement of any medication for chronic illness including Hormonal Replacement Ther-apy and enzyme modifiers.
18. Consumption of any prescribed medication (including herbal medicines and vitamin sup-plements) or OTC drugs during 21 days prior to dosing and till the end of the study.
19. Subject has a history of allergic response to foods, which are being used in the study meal.
20. Participation in any clinical study during 90 days prior to administration of study medica-tion.
21. Blood donation during 90 days prior to administration of study medication.
22. Clinically significant illness within 4 weeks before start of study.
23. Criteria for blood pressure and pulse:
- Systolic blood pressure below 110 mm of Hg or above 140 mm of Hg.
- Diastolic blood pressure below 70 mm of Hg or above 90 mm of Hg.
- Minor deviation (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician / investigator.
- Pulse rate below 70/ minute or above 100/ minute.
24. Subjects with any condition, which in the opinion of the investigators makes the subject unsuitable for inclusion.
25. Lactating or nursing female subjects.
26. Female subjects using hormonal contraceptive (either oral/implants).
27. Subjects tested and confirmed positive for latent tuberculosis before enrolling in a bioe-quivalence study.
28. Subjects with abnormal liver function tests, abnormal renal function test, blood counts, and lipid profiles at baseline prior to study drug administration. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the bioequivalence between Test product (T) and Reference product (R) under fasting conditions in healthy adult human subjects in a randomized crossover study  A total of 23 blood samples (5.0 mL each) will be collected at pre-dose (within 00.50 hour prior to dosing) and at 00.167, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 04.00, 06.00, 08.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose into pre-labelled vacutainers containing K3EDTA as an anticoagulant during each study period. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of a single oral dose of Tofacitinib 11mg XR extended-release tablets in healthy adult human subjects.  Kel, Tmax, t1/2, AUCRatio%, AUCExtrapolated % 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Bioequivalence Study of Tofacitinib 11mg XR extended-release tablets. 
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis and ulcerative colitis (UC)
A randomized, open label, balanced, two treatment, two period, two sequence, two way crossover, single oral dose, bioequivalence study of Tofacitinib 11mg XR extended-release tablets of Optimus Pharma Pvt. Ltd, India with XELJANZ® XR (Tofacitinib) 11 mg extended-release tablets marketed by Pfizer Labs Division of Pfizer Inc.NY. NY10017 in healthy adult human subjects under fasting conditions.
 
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