A Single-Dose,ComparativeBioavailability Study ofTwo Form... | NCT04145570

Studies
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

NCT04145570

Sponsor

Quadras Scientific Solutions

Status

Completed

Last Update Posted

Oct 30, 2019Actual

Enrollment

24Actual

Phase

Phase 4

Conditions

Lung Cancer

Interventions

Erlotinib HCl 150 mg
Tarceva®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2008Actual

Primary Completion Date

Nov 9, 2008Actual

Completion Date

Nov 9, 2008Actual

First Submitted Date

Oct 24, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2019

Last Update Posted Date

Oct 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gastón Kuperman, Doctor Clinical - Head of R&D, Quadras Scientific SolutionsPrincipal Investigator

Lead Sponsor

Quadras Scientific SolutionsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erlotinib HCl 150 mg	Experimental	Crossover	Drug: Erlotinib HCl 150 mg
Tarceva® 150 mg	Active Comparator	Crossover	Drug: Tarceva®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069347	Erlotinib Hydrochloride

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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%