Study of absorption and elimination rate of Tofacitinib 5-mg tablets in comparison with Tofacitinib brand tablets (Xeljanz®).
- Conditions
- Bioequivalence study.
- Registration Number
- IRCT20200407046981N47
- Lead Sponsor
- Kimia pharmaceutical Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
The weight limit of each volunteer should be between 60 and 100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Candidates who have consented to the consent form.
En Known hypersensitivity or idiosyncratic reaction to Tofacitinib or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Taking any medicine during two week before dosing.
Patients with serious infection (eg, sepsis) or active infection including local infection
Patients with active or latent tuberculosis, severe hepatopathy
Patients with absolute neutrophil count (ANC) less than 500 cells/mm3
Patients with an absolute lymphocyte count (ALC) of less than 500 cells per cubic millimeter
Patients whose hemoglobin level is less than 8 grams per deciliter
Patients with nephropathy (BUN<8 or BUN>20 or creatinine>1.5)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: 0 (before dosing),0.25, 0.5, 0.75, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve. Timepoint: 0 (before dosing), 0.25, 0.5, 0.75, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hour after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.