Phase IV 4 Way Crossover Study to Assess and Compare the Effect of a Single Nighttime Administration of Zolpidem, Silenor and Placebo on Arousability, Ataxia/Balance and Cognitive Performance in Healthy Volunteers.

Trial Profile

Phase IV 4 Way Crossover Study to Assess and Compare the Effect of a Single Nighttime Administration of Zolpidem, Silenor and Placebo on Arousability, Ataxia/Balance and Cognitive Performance in Healthy Volunteers.

Completed
Phase of Trial: Phase IV

Latest Information Update: 28 Feb 2017

At a glance

  • Drugs Doxepin (Primary) ; Zolpidem
  • Indications Insomnia
  • Focus Therapeutic Use
  • Sponsors Pernix Therapeutics Holdings
  • Most Recent Events

    • 16 Jun 2016 Primary endpoint has been met. (Auditory Arousal Threshold (AAT) at t-max), as reported in a Pernix Therapeutics media release.
    • 16 Jun 2016 According to a Pernix Therapeutics media release, results from this study were presented at the SLEEP 2016 International meeting.
    • 16 Jun 2016 Status changed from recruiting to completed, according to a Pernix Therapeutics media release.
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