This study is performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: Single-dose of Ventoclax 100 mg Tablets of The Test Drug (SOLANIX® 100 mg Tabs., Abidi Pharma, , in the first period. Cross-over design with two week washing period
Sponsors
Abidi Pharmaceutical Company
Eligibility
Sex/Gender
Female
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 female
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? 4? 5? 5.5? 6.0? 6.5? 7.0? 7.5? 8.0? 8.5? 9? 10? 12? 24? 48? 72 , 96 h after drug administration. 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