A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

NCT ID: NCT04145570

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-23
• Study Completion Date: 2008-11-09

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Erlotinib HCl 150 mg

Crossover

Group Type: EXPERIMENTAL

Erlotinib HCl 150 mg

Intervention Type: DRUG

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® 150 mg

Crossover

Group Type: ACTIVE_COMPARATOR

Tarceva®

Intervention Type: DRUG

Tarceva® 150 mg

Interventions

Erlotinib HCl 150 mg

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.

Intervention Type: DRUG

Tarceva®

Tarceva® 150 mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quadras Scientific Solutions

OTHER

Sponsor Role: lead

Responsible Party

Gastón Kuperman

Doctor Clinical - Head of R&D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2008-1877

Identifier Type: -

Identifier Source: org_study_id