In this study, the disease is not examined. The subject of the study is the bioequivalence study of Tofacitinib 5mg tablet of test and reference in healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention Group 1: Volunteers take Tofaxha 5mg tablet, which is manufactured by Zistdaru danesh Company and contains 5 mg of Tofacitinib ,as a test product, as a single oral dose, a
Sponsors
Zistdaru Danesh Company
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart and Kidney) Body Mass Index (18-28) Conscious Consciousness Age (18-60)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Pregnancy Alcoholism and Narcoticism History of allergy to Tofacitinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of concentration of drug in bood. Timepoint: After taking blood sample. Method of measurement: HPLC-MASS MASS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum concentration. Timepoint: After determining the amount of drug. Method of measurement: Observe drug concentrations at different times.;Area under curve. Timepoint: After determining the amount of drug. Method of measurement: Calculation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Ghasemian
Zistdaru Danesh company
Outcome results
None listed