A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

• Status: Completed
• Trial end date: 2008-11-09
• Target enrollment: 0
• Participant gender: All

Summary

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

• ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and

• Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Quadras Scientific Solutions
• Treatments: Erlotinib Hydrochloride

Criteria

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.