In-vivo Bioequivalence Test of Abiraterone tablet 500 mg Actero Middle East with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany)

In- Vivo Bioequivalence study of Abiraterone tablet 500 mg Actero Middle East Pharma (Abiraterone ACTe® 500 mg Tab.) with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N57

Enrollment

Registered

2022-04-05

Start date

2022-03-26

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group: One test tablet (Abiraterone tablet 500 mg produced by Actro Middle East Pharma) will be received. Blood samples will be taken for 72 hours at the mentioned times a

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-60 years old

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:5, 4, 6, 8, 10, 24, 48, 72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

Shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026