A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Sponsor
Quadras Scientific Solutions
Study ID
NCT04145570
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

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.
  • Tarceva® — DRUG
    Tarceva® 150 mg

Study Details

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

Key Dates

First listed
Oct 30, 2019
Start date
Oct 23, 2008
Status verified
Oct 2019
Primary completion
Nov 9, 2008
Completion
Nov 9, 2008

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Erlotinib HCl 150 mg
    Crossover
  • Active Comparator: Tarceva® 150 mg
    Crossover

Primary Outcome Measure

Bioequivalence (Biodisponibility) [ Time Frame: 72 hours ]

Related Studies