A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

NCT04145570 | Completed Phase 4 DMC

• 1 other identifier: 2008-1877
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Bioequivalence (Biodisponibility)

  Compared Bioequivalence

  72 hours

Study Arms (2)

Erlotinib HCl 150 mg

EXPERIMENTAL

Crossover

Drug: Erlotinib HCl 150 mg

Tarceva® 150 mg

ACTIVE COMPARATOR

Crossover

Drug: Tarceva®

Interventions

Erlotinib HCl 150 mg 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.

Erlotinib HCl 150 mg

Tarceva® DRUG

Tarceva® 150 mg

Tarceva® 150 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects
• Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quadras Scientific Solutions: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Clinical - Head of R&D

Model Details: 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%

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 30, 2019
• Study Start: October 23, 2008
• Primary Completion: November 9, 2008
• Study Completion: November 9, 2008
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share