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A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users

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Trial Profile

A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Nov 2024

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At a glance

  • Drugs Buprenorphine (Primary) ; Oxycodone
  • Indications Pain
  • Focus Pharmacodynamics
  • Sponsors BioDelivery Sciences International

Most Recent Events

  • 07 Nov 2024 According to a Collegium Pharmaceutical media release, company presented poster highlighting data from this study at PAINWeek Conference 2024.
  • 28 Aug 2024 According to a Collegium Pharmaceutical media release, poster of A Review of the Primary and Secondary Outcomes From a Phase I Study Comparing the Respiratory Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration from this trial will be presented at PAINWeek Conference 2024, being held in Las Vegas, NV, from September 3-6, 2024.
  • 07 May 2022 Results of a secondary analysis assessed the pharmacokinetic parameters and oxygen saturation as markers of abuse potential after administration of buprenorphine buccal film and immediate-release (IR) oxycodonepublished in the Pain and Therapy

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