A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
- Registration Number
- NCT04145570
- Lead Sponsor
- Quadras Scientific Solutions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Erlotinib HCl 150 mg Erlotinib HCl 150 mg Crossover Tarceva® 150 mg Tarceva® Crossover
- Primary Outcome Measures
Name Time Method Bioequivalence (Biodisponibility) 72 hours Compared Bioequivalence
- Secondary Outcome Measures
Name Time Method