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A phase 1, open label, non-randomized study to evaluate the PK, safety and tolerability of durlobactam (500 or 1000 mg) and sulbactam (500 or 1000 mg) in healthy subjects with normal renal function, subjects with mild, moderate or severe renal impairement and subjects with end stage renal disease on haemodialysis

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Trial Profile

A phase 1, open label, non-randomized study to evaluate the PK, safety and tolerability of durlobactam (500 or 1000 mg) and sulbactam (500 or 1000 mg) in healthy subjects with normal renal function, subjects with mild, moderate or severe renal impairement and subjects with end stage renal disease on haemodialysis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Jul 2019

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At a glance

  • Drugs Durlobactam/sulbactam (Primary)
  • Indications Renal failure; Renal impairment
  • Focus Adverse reactions; Pharmacokinetics

    • Most Recent Events

    • 19 Jul 2019 New trial record
    • 15 Jul 2019 Results published in the Antimicrobial Agents and Chemotherapy.

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