A Phase 1 Crossover Study to Evaluate the Pharmacokinetics (PK) and Safety of Two Formulations of a 7-Day Application of Memantine Transdermal Delivery System (TDS) Compared to Oral Administration of NAMENDA XR and to assess TDS adhesion in Healthy 50-80 year old Volunteers

Trial Profile

A Phase 1 Crossover Study to Evaluate the Pharmacokinetics (PK) and Safety of Two Formulations of a 7-Day Application of Memantine Transdermal Delivery System (TDS) Compared to Oral Administration of NAMENDA XR and to assess TDS adhesion in Healthy 50-80 year old Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Sep 2016

At a glance

  • Drugs Memantine (Primary) ; Memantine
  • Indications Alzheimer's disease
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Corium International
  • Most Recent Events

    • 21 Sep 2016 Planned number of patients changed from 36 to 48.
    • 13 Sep 2016 Status changed from active, no longer recruiting to completed.
    • 24 Aug 2016 Summary results from this trial were used for Pre-Investigational New Drug Application (PIND) submission of once-weekly transdermal Corplex Memantine. Company received favourable written feedback from the U.S. Food and Drug Administration (FDA) on the PIND, as reported by a Corium International media release.
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