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Bioequivalence study of Abirateron 500mg tablet (Bratiga) manufactured by Abidi Co versus originator brand (Zytiga 500) manufactured by Janssen biotech Co. in Iranian healthy volunteers
Study aim: Bioequivalence study of Abirateron 500 mg tablet manufactured by Abidi Co. versus originator brand (Zytiga) manufactured by Janssen Biotech in Iranian healthy volunteers. Design: Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization Settings and conduct: The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (72h). The interval between these two periods is a week. In the first round of the study, the candidates were divided into two groups the first group received a test tablet and the second group received a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. Sampling is performed in Radin laboratory in Tabriz. Participants/Inclusion and exclusion criteria: Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Abirateron Intervention groups: Intervention group 1: Zytiga 500 mg tablet manufactured by Janssen biotech as a reference Intervention group 2: Bratiga 500mg manufactured by Abidi as a test Main outcome variables: Maximum drug concentration, Time to reach maximum drug concentration
IRCTID: IRCT20200105046010N87
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