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A phase 1 bioequivalence study of HTX-019 intravenous (IV) injection compared to oral Aprepitant in patients with Postoperative nausea and vomiting (PONV)

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A phase 1 bioequivalence study of HTX-019 intravenous (IV) injection compared to oral Aprepitant in patients with Postoperative nausea and vomiting (PONV)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Aprepitant (Primary) ; Aprepitant
  • Indications Postoperative nausea and vomiting
  • Focus Adverse reactions; Pharmacokinetics

    • Most Recent Events

    • 26 Oct 2022 Results assessing Bioavailability Study Of Htx-019 Intravenous Injection Compared With Aprepitant Oral Capsules presented at the ANESTHESIOLOGY 2022 Annual Meeting of the American Society of Anesthesiologists
    • 16 Sep 2022 According to Heron Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.
    • 28 Feb 2022 According to a Heron Therapeutics media release, NDA Submission for HTX-019 for prevention of PONV in adults accepted by FDA with a PDUFA goal date of September 17, 2022.

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