A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

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

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.

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.