Bioequivalence study of Sirolimus 1mg tablet

Bioequivalence study of Sirolimus 1mg manufactured by Zist takhmir company versus originator brand in healthy volunteers in fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N35

Enrollment

Registered

2023-05-10

Start date

2023-06-20

Completion date

Unknown

Last updated

2023-05-29

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 and drug concentration in whole blood is determined..

Interventions

Intervention 1: Intervention group: single dose, 3 oral tablet 1mg (Rapamune) manufactured by Pfizer, as a reference product. Intervention 2: Intervention group: Single dose, 3 oral Sirolimus 1mg tabl

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 Alcoholism and Narcoticism History of allergy to Sirolimus

Design outcomes

Primary

Measure	Time frame
Drug concentration in blood. Timepoint: 0; 0.33, 0.66; 1; 1.33; 1.66, 2; 3; 4; 6; 8; 10; 12; 24; 48; 72h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas.	—

Secondary

Measure	Time frame
Time to reach maximum drug concentration in blood. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration is recorded.;Extent of drug absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

Ghasemian_elham@yahoo.com+98 23 3522 5046

Outcome results

None listed

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