In-vivo Bioequivalence Test of Erlotinib tablets with brand drug (TARCEVA® 150 mg, Rosche, Switzerland)

in- Vivo Bioequivalence study of Erlotinib tablet 150 mg Abidi Pharma (LOTIVA® 150 mg) with brand drug (TARCEVA® 150 mg, Rosche, Switzerland) in Iranian healthy volunteers.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N51

Enrollment

Registered

2021-12-27

Start date

2021-12-25

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 (Erlotinib tablet 150 mg produced by Abidi Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug adm

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, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 24, 48, 72 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