Study of absorption and elimination rate of Erlotinib 150 mg tablets in comparison with standard tablet of Erlotinib (Tarceva).

Randomized, single-dose, crossover comparative bioequivalence study of the Erlotinib 150 mg tablets produced by Kimia pharmaceutical Co versus Tarceva® (Roche company) in 30 healthy males under fasting conditions

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200407046981N7

Enrollment

Registered

2021-03-26

Start date

2021-03-14

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Lung and pancreatic cancer.

Interventions

Intervention 1: Intervention group (Test): Erlotinib 150 mg tablets, produced by Kimia pharmaceutical Co. is the test product. In each period, 15 of 30 subjects will be given single oral dose of this

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The weight limit for each volunteer between 60-100 kg. All volunteers must be non-smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics

Exclusion criteria

Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Erlotinib or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg Taking any medicine during two week before dosing.

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax), AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before intervention), 0.5? 1?1.5? 2? 2.5? 3? 5? 4? 6? 8? 12? 24? 48? 72 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS) and using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups.	—

Measure

Time frame

Peak Plasma Concentration (Cmax), AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before intervention), 0.5? 1?1.5? 2? 2.5? 3? 5? 4? 6? 8? 12? 24? 48? 72 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS) and using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hamed Hamishehkar

Tabriz University of Medical Sciences

Hamishehkar.hamed@gmail.com+98 41 3336 7914

Outcome results

None listed

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