A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

• ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
• Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Erlotinib HCl 150 mg; Drug: Tarceva®

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erlotinib HCl 150 mg; Crossover	Drug: 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.
Active Comparator: Tarceva® 150 mg; Crossover	Drug: Tarceva®; Tarceva® 150 mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Quadras Scientific Solutions

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2008
• Primary Completion (Actual): November 9, 2008
• Study Completion (Actual): November 9, 2008

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: 2008-1877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No