A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept

Trial Profile

A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Aug 2018

At a glance

  • Drugs Donepezil (Primary) ; Donepezil
  • Indications Alzheimer's disease
  • Focus Pharmacokinetics; Registrational
  • Sponsors Corium International
  • Most Recent Events

    • 31 Jul 2018 Status changed to completed.
    • 14 May 2018 According to a Corium International media release, based on this study, the company is planning to a submission of a Section 505(b)(2) New Drug Application (NDA) in the first quarter of 2019.
    • 24 Apr 2018 Planned End Date changed from 1 Aug 2018 to 1 Dec 2018.
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