In-vivo Bioequivalence Study of Osimertinib® 80 mg FC.Tablets of The Test Drug (MERTISSO® 80 mg FC Tabs., Nano Alvand, Iran)

In-vivo Bioequivalence Study of Osimertinib® 80 mg FC.Tablets of The Test Drug (MERTISSO® 80 mg FC Tabs., Nano-Alvand, Iran) in Compared with The Reference Drug (TAGRISSO® 80 mg FC. Tablets., Lilly) In Iranian Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N119

Enrollment

Registered

2024-09-06

Start date

2024-09-03

Completion date

Unknown

Last updated

2024-09-16

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 and drug concentration in plasma is determined..

Interventions

Intervention 1: Control Control: Single dose, one oral tablet (TAGRISSO® 80 mg Tab., Lilly) as a reference product. after washout period, the volunteers will receive the Test Tablets. Intervention 2:

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent Age (18-55 years old)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10,12, 24, 48 and 72 hours after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Nemati

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