This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: Single-dose of Osimertinib 80 mg FC. Tablets of Actero in the first period. Cross-over design with four week washing period. Intervention 2: Intervention group: Si
Sponsors
Actro Middle East Pharmaceutical Co
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: General health (liver, heart, kidney) of volunteers Body mass index range (18-30) Informed consent form Age between18-55
Exclusion criteria
Exclusion criteria: Smoking Having a history of cardiovascular disease Having a history of liver & kidney disease Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy
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. Method of measurement: Liquid Chromatography with Mass-Mass Detector. | — |
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