Bioequivalence Study of Tofacitinib 11 mg Extended Release Tablets in a fasting condition
- Registration Number
- CTRI/2022/07/043974
- Lead Sponsor
- Optimus Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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)].
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, bloodâ??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 ma
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method