Bioequivalence study.
Conditions
Interventions
Intervention 1: Intervention group: In this group, volunteers are given a single oral dose of Tofacitinib 5mg tablets produced by Noavaran Daroui Kimia Co. (Domestic). In each period, 12 of 24 subject
Sponsors
Kimia pharmaceutical Co
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 (BUN20 or creatinine>1.5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatima Molavi
Tabriz University of Medical Sciences
Outcome results
None listed