In-vivo Bioequivalence Test of Tenofovir Alafenamide tablets with brand drug (Vemlidy® 25 mg, Gilead, Canada)

In- Vivo Bioequivalence study of Tenofovir Alafenamide tablets 25 mg (Sobhan Trade Co, Iran) with brand drug (Vemlidy® 25 mg, Gilead, Canada) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N52

Enrollment

Registered

2022-01-03

Start date

2021-12-29

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Bio equivalence test.

Interventions

Intervention 1: Intervention group: One test tablet (Tenofovir Alafenamide tablets 25 mg produced by Sobhan Trade Pharma.) will be received. Blood samples will be taken for 24 hours at the mentioned t

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 0:15, 0:30, 0:45, 1, 1:15, 1:30, 2:00, 2:30, 3, 4, 6, 8, 10, 24 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.	—

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