A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

October 29, 2019 updated by: Gastón Kuperman, Quadras Scientific Solutions

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 72 hours
Compared Bioequivalence
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quadras Scientific Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe