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A Single-Center, Randomized, Four-Way Crossover, Open-Label, Dose-Ranging, Pharmacokinetic and Pharmacodynamic Study to Compare Zolpidem Oral Spray with Zolpidem (Ambien) Tablets in Healthy Volunteers

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Trial Profile

A Single-Center, Randomized, Four-Way Crossover, Open-Label, Dose-Ranging, Pharmacokinetic and Pharmacodynamic Study to Compare Zolpidem Oral Spray with Zolpidem (Ambien) Tablets in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Aug 2019

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At a glance

  • Drugs Zolpidem (Primary) ; Zolpidem
  • Indications Insomnia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors NovaDel Pharma
  • Most Recent Events

    • 05 Aug 2019 According to an Aytu BioScience media release, post-hoc analysis results of data from this trial were published today in the journal Pharmacy and Pharmacology.
    • 05 Aug 2019 Post-hoc analysis of data from this trial presented in an Aytu BioScience media release.
    • 10 Aug 2006 New trial record.

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