Bioequivalence study of Tofacitinib 10 mg tablet
Not Applicable
Recruiting
- Conditions
- This study is performed on healthy volunteers..
- Registration Number
- IRCT20200105046010N79
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion Criteria
smoking
alcohol and drug addiction
history of allergy to Tofacitinib
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The concentration of the drug in blood. Timepoint: Pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.
- Secondary Outcome Measures
Name Time Method Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: Clock.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.