In-vivo Bioequivalence Test of NEORAPA® tablet with brand drugs (AFINITOR® 10mg Novartis).

In- Vivo Bioequivalence study of Everolimus tablet 10mg ABIDI (NEORAPA® 10mg) with brand drug (AFINITOR® 10mg Novartis) in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N24

Enrollment

Registered

2021-02-23

Start date

2021-05-31

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

In this study, the disease is not examined. Subject bioequivalence test and reference tablets Everolimus studied..

Interventions

Intervention 1: Intervention group: Intervention group received one test drug table(Everolimus tablet 10mg ABIDI Pharmaceutical Company). Blood samples were taken from the volunteers for 72 hours at

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index(18-28) Informed consent Age(18-60)

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
Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet. Method of measurement: igh 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