This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral capsule Gilenya 0.5 mg manufactured by Novartis as a reference product. after the washout period, the volunteers receive Norabex 0.5mg capsule
Sponsors
Abidi 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 Alcoholism and Narcoticism History of allergy to Fingolimod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: 0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 96, 144, 216, 288 and 360h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma 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