A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

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

Detailed Description
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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.

Official Title
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A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib HCl 150 mg
* Drug: Tarceva®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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%
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib HCl 150 mg<br>Crossover | Drug: Erlotinib HCl 150 mg<br>* 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.<br>|
| Active Comparator: Tarceva® 150 mg<br>Crossover | Drug: Tarceva®<br>* Tarceva® 150 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence (Biodisponibility) | Compared Bioequivalence | 72 hours |