This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: This study examines the bioequivalence of fingolimod capsules produced by Alborzagros company versus foreign brand samples. There is only one intervention group and no control group. T
Sponsors
Alborz Zagros company
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 fingolimod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of the drug in blood. Timepoint: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 and 72 h 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 ContactElham Ghasemian
Islamic Azad University
Outcome results
None listed