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A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

NCT04145570 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-10-30

No results posted yet for this study

Summary

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

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

Conditions

Interventions

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.

DRUG

Tarceva®

Tarceva® 150 mg

Sponsors & Collaborators

  • Quadras Scientific Solutions

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-23
Primary Completion
2008-11-09
Completion
2008-11-09

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145570 on ClinicalTrials.gov