A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04145570

Enrollment

Registered

2019-10-30

Start date

2008-10-23

Completion date

2008-11-09

Last updated

2019-10-30

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

Conditions

Lung Cancer

Brief summary

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween: * ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and * Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

Detailed description

This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions. • SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Interventions

DRUGErlotinib HCl 150 mg

Concentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures. dosing in each period.

DRUGTarceva®

Tarceva® 150 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Based on the log-transformed parameters, the following criteria were used to evaluate the bioequivalence between the test and reference products: * The 90% confidence interval of the relative mean AUCt of the test to reference products should be between80% and125%. * TherelativemeanCmaxofthetesttoreferenceproductsshouldbebetween80% and125%

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects * Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

Exclusion criteria

* Known history or presence of any clinically significant medicalcondition. * Known or suspected carcinoma. * Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year. * Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. * Use of tobacco or nicotine-containing products within 6 months priorto drug administration.

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence (Biodisponibility)	72 hours	Compared Bioequivalence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026