Trial Profile

Bridging study investigating bioequivalence of apomorphine sublingual thin film strip.

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 06 Jan 2017

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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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