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A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of ORAvance (Ceftibuten/Xeruborbactam Oral Prodrug [QPX7831]) in Participants With Renal Impairment

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Trial Profile

A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of ORAvance (Ceftibuten/Xeruborbactam Oral Prodrug [QPX7831]) in Participants With Renal Impairment

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 May 2025

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At a glance

  • Drugs Ceftibuten (Primary) ; QPX 7831 (Primary)
  • Indications Bacterial infections
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Qpex Biopharma

Most Recent Events

  • 14 May 2025 Status changed from recruiting to completed.
  • 26 Feb 2025 Planned primary completion date changed from 1 Feb 2025 to 1 Apr 2025.
  • 26 Feb 2025 Status changed from not yet recruiting to recruiting.

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