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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
IRCTID: IRCT20200105046010N57
  1. In- Vivo Bioequivalence study of Abiraterone tablet 250 mg Sobhan Oncology Pharma (Abiraterone ® 250 mg Tab.) with brand drug (ZYTIGA® 250 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.
  2. In- Vivo Bioequivalence study of Abiraterone tablet 500 mg Nano-Alvand (ZYBERON® 500 mg Tab ) Pharma. with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.
  3. In- Vivo Bioequivalence study of Daclaasvir/Sofosbuvir 60/400 mg Actero Middle East Pharma (DATEX 400/60 mg Tab.) with brand drug (Sofosbovir/Daclatasivir® 400/60 mg, Mylan, Germany) in Iranian healthy volunteers.
  4. In- Vivo Bioequivalence study of Linalidomide capsule 25 mg (Actero Pharma., Iran) with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb,UK) in Iranian healthy volunteers.
  5. In- Vivo Bioequivalence study of Sorafenib tablet 200 mg Actro Middle East with brand drug (NEXAVAR® 200 mg, Bayer, Germany) in Iranian healthy volunteers.
  6. In- Vivo Bioequivalence study of Erlotinib tablet 150 mg Actero Pharma. with brand drug (TARCEVA® 150 mg, Rosche, Switzerland) in Iranian healthy volunteers.
  7. 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
  8. Comparative Bioequivalence Study of the Eltrombopag 50 mg Tablet Manufactured by Actero Middle East Pharmaceutical Company by Innovative Company
  9. Bioequivalence study of Abiraterone 250 mg film coated tablets manufactured by Noavaran Daroui Kimia Pharmaceutical Company vs. Zytiga ® tablets manufactured by Janssen Biotech Company in healthy volunteers
  10. In- Vivo Bioequivalence study of Ibuprofen tablet 800 mg Mofid Pharma (DRASTIFEN® ER. 800 mgTab, Mofid Pharma, Iran) with brand drugs (BRUFEN® ER. 800 mg Tab, Mylan, Germany) in Iranian healthy volunteers.
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