In-vivo Bioequivalence Study of Enzalotamide 40 mg Tablets of The Test Drug (TENZALA® 40 mg Tabs., Nano-Alvand Pharma, Iran)

In-vivo Bioequivalence Study of Enzalotamide 40 mg Tablets of The Test Drug (TENZALA® 40 mg Tabs., Nano-Alvand Pharma, Iran) in Compared with The Reference Drug (XTANDI® 40 mg Tabs, Astellas Pharma Europe) In Iranian Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N164

Enrollment

Registered

2025-12-29

Start date

2026-02-04

Completion date

Unknown

Last updated

2026-02-02

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 Enzalotamide 40 mg Tablets of The Nano-Alvand Pharma in the first period. Cross-over design with four week washing period. Intervention 2: Intervent

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 form Age between18-55

Exclusion criteria

Exclusion criteria: Smoking Having a history of cardiovascular disease Having a history of liver & kidney disease Having a Alcohol & Drug addiction Having a hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
The concentration of the drug in blood. Timepoint: 0? 0.33? 0.66? 1? 1.5? 2.5? 3? 3.5? 4? 4.5? 5? 5.5? 6? 7? 8? 10? 12? 24? 48 , 72h after drug administration. Method of measurement: Liquid Chromatography with Mass-Mass Detector.	—

Secondary

Measure	Time 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 3661 4125

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026