Bioequivalence study of Everolimus 0.75mg tablet

Bioequivalence study of Everolimus 0.75mg manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N12

Enrollment

Registered

2022-01-01

Start date

2021-12-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: single dose, 2 oral tablet 0.75mg (Certican) manufactured by Novartis, as a reference product. Intervention 2: Intervention group: Single dose, 2 oral tablet 0.75mg

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to Everolimus

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0; 0.5; 1; 1.5;2; 2.5; 3; 4; 6; 8; 10; 12; 24; 48; 72h after drug administration. Method of measurement: Liquid Chromatography -MASS-MASS (LC-MASS/MASS).	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

Ghasemian_elham@yahoo.com+98 21 4163 7000

Outcome results

None listed

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