This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group 1: single dose, one oral tab Mayzent 2 mg manufactured by Novartis as a reference product. after the washout period, the volunteers receive Relapzent 2 mg tab manufa
Sponsors
Zistdaru danesh 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 of 18-65 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 siponimod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma. Timepoint: Before and 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, 48, and 96 hours after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum drug concentration in plasma. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration is recorded.;Extent of drug absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Ghasemian
Radin Laboratory
Outcome results
None listed