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A Phase 1, Open-Label, Non-Randomized, Parallel-Group Study to Characterize and Compare the Pharmacokinetics, Safety, and Tolerability of Escalating Oral Doses of Nalbuphine Hydrochloride Extended Release Tablets in End-Stage Renal Disease Patients on Hemodialysis and Matched Healthy Control Subjects

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Trial Profile

A Phase 1, Open-Label, Non-Randomized, Parallel-Group Study to Characterize and Compare the Pharmacokinetics, Safety, and Tolerability of Escalating Oral Doses of Nalbuphine Hydrochloride Extended Release Tablets in End-Stage Renal Disease Patients on Hemodialysis and Matched Healthy Control Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Jan 2023

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At a glance

  • Drugs Nalbuphine (Primary)
  • Indications Pruritus
  • Focus Pharmacokinetics
  • Sponsors Trevi Therapeutics

    • Most Recent Events

    • 12 Jan 2023 Results of population pharmacokinetic-pharmacodynamic model assessing efficacy of nalbuphine ER in patients with prurigo nodularis from two clinical trials (NCT02373215: 9 healthy subjects; NCT02174419: 62 subjects with PN), published in the British Journal of Clinical Pharmacology.
    • 03 Mar 2015 New trial record

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