Bioequivalence study of erlotinib 150 mg

Bioequivalence study of erlotinib150mg tablet, manufactured by Zistdaru Danesh co. (Erloxha) Versus Tarceva 150 in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N6

Enrollment

Registered

2021-08-14

Start date

2021-09-06

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

In this study, the disease is not examined. The subject of the study is the bioequivalence study of Erlotinib tablet 150 mg of test and reference in healthy volunteers..

Interventions

Intervention 1: Intervention group: single dose, one oral tablet of Tarceva 150 mg (Erlotinib) manufactured by Roche, as reference product. Intervention 2: Intervention group: Single dose, one oral ta

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-60 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to erlotinib

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: Before, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 36,48 and 72h after drug consumption. Method of measurement: HPLC -MASS-MASS.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Zistdaru Danesh company

ghasemian@zistdaru.ir+98 21 6696 5196

Outcome results

None listed

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