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Study aim:
In- Vivo Bioequivalence study of Abiraterone tablet 500 mg Actro Middle East Pharma with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.
Design:
In-vivo bioequivalence study of Abiraterone tablet 500 mg Middle East Pharma in comparison with reference drug (ZYTIGA® 500 mg, Janssen Biotech, Germany). The single blind, Cross-over, two period, two groups (Intervention and control) and randomized (paper lottery randomization method) study with one week wash-out time.
Settings and conduct:
This study is carried out in Simin Baspar Tayf-Gostar Company, Tabriz, Iran. The study population is 24 healthy Iranian volunteers.This study is a single blind study and by taking out the drugs from the existing packaging, the volunteers will not know the time of receiving the test drug and the brand. This study is a cross over study that is performed in two time periods of 72 hours with a two-week wash-out period.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: age between 18-55 years old; body mass index (BMI) in the range of 18-28. Exclusion criteria: history of heart, kidney and liver disease; pregnancy; drug addiction; smoking
Intervention groups:
Single dose Abiraterone tablet 500 mg Actro Middle East Pharma. Control group: brand drugs (ZYTIGA® 500 mg, Janssen Biotech, Germany)
Main outcome variables:
Plasma drug concentration