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Bioequivalence study of Everolimus 10 mg tablets manufactured by Actro Khavarmianeh Pharmaceutical Company

Bioequivalence study of Everolimus 10 mg tablets manufactured by Actro Khavarmianeh Pharmaceutical Company compared to the brand name drug (AFINITOR® 10 mg Tabs, Novartis, Germany) in healthy Iranian volunteers.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200105046010N151
Enrollment
24
Registered
2025-09-02
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

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 of Everolimus 10 mg Tablets manufactured by Actro Khavarmianeh Pharmaceutical Company, in the first period. Cross-over design with two weeks washing per

Sponsors

Actro Khavarmianeh Pharmaceutical Co
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health (liver, heart, kidney) of volunteers Body mass index range (18-30) Informed consent formAge between18-55

Exclusion criteria

Exclusion criteria: Smoking Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy

Design outcomes

Primary

MeasureTime frame
The concentration of the drug in blood. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.

Secondary

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

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