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A Nonrandomized, Open-Label, Multicenter, Phase 1 Study to Assess the Safety and Pharmacokinetics of ADASUVE(R) (STACCATO(R) Loxapine for Inhalation) at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication

Trial Profile

A Nonrandomized, Open-Label, Multicenter, Phase 1 Study to Assess the Safety and Pharmacokinetics of ADASUVE(R) (STACCATO(R) Loxapine for Inhalation) at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jun 2018

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At a glance

  • Drugs Loxapine (Primary)
  • Indications Agitation
  • Focus Pharmacokinetics
  • Sponsors Teva Branded Pharmaceutical Products R&D
  • Most Recent Events

    • 15 Feb 2017 Results published in the Clinical Pharmacokinetics.
    • 21 Aug 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 06 Aug 2015 According to Alexza Pharmaceuticals media release, Teva expects to file the clinical study report later in 2015 with the U.S. Food and Drug Administration.
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