This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: single dose, one oral tablet 80 mg(Tagrisso) manufactured by Lilly, as a reference product. Intervention 2: Intervention group: Single dose, one oral Osixha 80 mg
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 (18-55 years old)
Exclusion criteria
Exclusion criteria: SmokingHistory of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to osimertinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of the drug in blood. Timepoint: 0, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 24, 48, 72, 96h 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 ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed