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A Phase 1 Crossover Study to Assess the Bioequivalence of Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Subjects

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A Phase 1 Crossover Study to Assess the Bioequivalence of Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jul 2021

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At a glance

  • Drugs Isavuconazonium (Primary) ; Isavuconazonium
  • Indications Candidiasis; Invasive bronchopulmonary aspergillosis; Mycoses; Zygomycosis
  • Focus Pharmacokinetics
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 28 Jun 2021 Results published in the Antimicrobial Agents and Chemotherapy
    • 25 Oct 2020 Primary endpoint (PK of isavuconazole in plasma: maximum concentration (Cmax)), has been met according to results presented at the IDWeek 2020
    • 25 Oct 2020 Primary endpoint (PK of isavuconazole in plasma: area under the concentration-time curve from 0 to 72 hours (AUC72)), has been met according to results presented at the IDWeek 2020

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