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A Phase 1, Single-Centre, Part-Crossover, OpenLabel, Partially-Randomised Study Designed to Evaluate the PK Profile of Piroxicam Following Administration of Nanoformed Oral IR Piroxicam Tablet and an IR Reference Product in Healthy Subjects

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A Phase 1, Single-Centre, Part-Crossover, OpenLabel, Partially-Randomised Study Designed to Evaluate the PK Profile of Piroxicam Following Administration of Nanoformed Oral IR Piroxicam Tablet and an IR Reference Product in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Piroxicam (Primary) ; Piroxicam; Piroxicam betadex
  • Indications Cardiovascular disorders; Depression; Epilepsy; Erectile dysfunction; Inflammation; Migraine; Pain; Stroke; Vertigo
  • Focus First in man; Pharmacokinetics
  • Acronyms UNICORN
  • Sponsors Nanoform

    • Most Recent Events

    • 17 May 2021 Status changed from recruiting to completed, according to a Nanoform Media Release.
    • 17 May 2021 According to a Nanoform Media Release, final results are based on the cohort of twelve healthy volunteers dosed in December 2020 and January 2021 at Quotient Sciences' facilities in Nottingham, UK.
    • 17 May 2021 Primary endpoint (PK and relative bioavailability of piroxicam in the fasted state (Tmax, Cmax, (AUC(0-1) (AUC(0-last)))) has been met, according to a Nanoform Media Release.

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