This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: Single-dose of the test drug Tofacitinib 5 mg Tablet of (TOFAJUS® 5 mg® Abureyhan, Iran) in the first period. Intervention 2: Control group: Single-dose of the The
Sponsors
Aburayhan Pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)
Exclusion criteria
Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of the drug in blood. Timepoint: 0? 0.25? 0.5? 1? 1.25? 1.5? 2? 2.5? 3? 4? 6? 8? 10? 12, 24h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed