Bridging study investigating bioequivalence of apomorphine sublingual thin film strip.
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
- 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.