A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Quadras Scientific Solutions24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Erlotinib HCl 150 mgDRUG

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.

Tarceva®DRUG

Tarceva® 150 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence (Biodisponibility)

Compared Bioequivalence

Time frame: 72 hours

Data from ClinicalTrials.gov

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