This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral capsule of Tecfidera 240 mg manufactured by Biogen, as a reference product. Intervention 2: Intervention group: Single dose, one oral capsule
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 dimethyl fumarate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of the active metabolite in plasma. Timepoint: Pre-dose, 0.33, 0. 66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 5, 7, and 10 h 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: The time to reach the maximum metabolite 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 ContactElham Ghasemian
Islamic Azad University
Outcome results
None listed