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

In- Vivo Bioequivalence study of Everolimus tablet 10 & 0.75 mg SOBHAN ONCOLOGY (Everolimus 10mg) with brand drug (AFINITOR® 10mg Novartis) in Iranian healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N44

Enrollment

Registered

2021-11-15

Start date

2021-11-11

Completion date

Unknown

Last updated

2021-11-29

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 bio equivalence test and reference tablets Everolimus studied..

Interventions

Intervention 1: Intervention group: they will receive one test drug (Everolimus 10 or 0.75 mg Tablets SOBHAN ONCOLOGY. Iran). Blood samples will be taken during 72 hours at the mentioned times after d

Eligibility

Sex/Gender

Male

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 History of cardiovascular disease History of liver or kidney disease Pregnancy Alcohol & Drug addiction History of hypersensitivity

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: High Performance Liquid Chromatography tandem mass spectroscopy.	—

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