Bridging study investigating bioequivalence of apomorphine sublingual thin film strip.

Trial Profile

Bridging study investigating bioequivalence of apomorphine sublingual thin film strip.

Completed
Phase of Trial: Phase II

Latest Information Update: 10 Dec 2015

At a glance

  • Drugs Apomorphine (Primary) ; Apomorphine (Primary)
  • Indications Parkinson's disease
  • Focus Pharmacokinetics; Registrational
  • Sponsors Cynapsus Therapeutics
  • Most Recent Events

    • 10 Dec 2015 According to a Cynapsus Therapeutics media release, results of this study are expected to be submitted to the U.S. FDA as part of a U.S. new drug application (NDA) submission, as well as to European regulatory authorities as part of a European submission.
    • 10 Dec 2015 Status changed from planning to completed, according to a Cynapsus Therapeutics media release.
    • 18 Mar 2015 Planned initiation date changed from 1 Oct 2014 to 1 Jun 2015, as reported in a Cynapsus Therapeutics media release.
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