A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Lung Cancer Clinical Trial

Official title:

A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145570
• Other study ID #: 2008-1877
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2008
• Est. completion date: November 9, 2008

Study information

• Verified date: October 2019
• Source: Quadras Scientific Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

• ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and

• Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 9, 2008
• Est. primary completion date: November 9, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.
• Tarceva®
Tarceva® 150 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quadras Scientific Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence (Biodisponibility)	Compared Bioequivalence	72 hours