This study is performed on healthy volunteers and drug concentration in plasma is determined..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablet Myfortic 360mg manufactured by Novartis as a reference product. after the washout period, the volunteers receive Mynalic 360 mg tablet
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 Mycophenolic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma. Timepoint: 0, 0.5, 1, 1.33, 1.66, 2, 3, 4, 6, 7, 8, 10, 24, 48 h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas). | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent of drug absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.;Time to reach maximum drug concentration in plasma. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration is recorded. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Ghasemian
Islamic Azad University
Outcome results
None listed