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A Randomized, Open-label, PK and Safety Study to Evaluate the Relative Exposure and Safety of a New Formulation vs the Approved Formulation of a Single 1200 mg IV Dose of ORBACTIV (Oritavancin) in Subjects Being Treated for ABSSSI

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Trial Profile

A Randomized, Open-label, PK and Safety Study to Evaluate the Relative Exposure and Safety of a New Formulation vs the Approved Formulation of a Single 1200 mg IV Dose of ORBACTIV (Oritavancin) in Subjects Being Treated for ABSSSI

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Oritavancin (Primary)
  • Indications Abscess; Bacterial infections; Bacterial skin diseases; Cellulitis; Erysipelas; Gram-positive infections; Skin infections; Wound infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Melinta Therapeutics

Most Recent Events

  • 15 Mar 2021 According to a Melinta Therapeutics media release, Michael Waters, M.D. is lead investigator of the trial.
  • 15 Mar 2021 According to a Melinta Therapeutics media release, based on the results from this trial he U.S. Food and Drug Administration (FDA) has approved KIMYRSA™ (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).
  • 02 Dec 2019 Status changed from active, no longer recruiting to completed.

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