A proof-of-concept study, single-dose, cross-over, comparative bioavailability of AQS-1303 (transdermal doxylamine/pyridoxine long-acting patch), for the treatment of nausea and vomiting of pregnancy (NVP)

Trial Profile

A proof-of-concept study, single-dose, cross-over, comparative bioavailability of AQS-1303 (transdermal doxylamine/pyridoxine long-acting patch), for the treatment of nausea and vomiting of pregnancy (NVP)

Completed
Phase of Trial: Phase I

Latest Information Update: 07 Sep 2017

At a glance

  • Drugs Doxylamine/pyridoxine (Primary) ; Doxylamine/pyridoxine
  • Indications Nausea and vomiting
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept
  • Sponsors Aequus Pharmaceuticals
  • Most Recent Events

    • 07 Sep 2017 According to an Aequus Pharmaceuticals media release, the company will incorporate the results from this study into a pre-Investigational New Drug (pre-IND) submission with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US.
    • 07 Sep 2017 Status changed from recruiting to completed, according to an Aequus Pharmaceuticals media release.
    • 07 Sep 2017 Results presented in an Aequus Pharmaceuticals media release.
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