A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Quadras Scientific Solutions

Status and phase

Completed

Phase 4

Conditions

Lung Cancer

Treatments

Drug: Tarceva®

Drug: Erlotinib HCl 150 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04145570

2008-1877

Details and patient eligibility

About

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.