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A Phase 1 Open-Label, Multicenter, Single and Multiple Ascending Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Lurasidone in Subjects 6 to 17 Years Old With Schizophrenia Spectrum, Bipolar Spectrum, Autistic Spectrum Disorder, or Other Psychiatric Disorders

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Trial Profile

A Phase 1 Open-Label, Multicenter, Single and Multiple Ascending Dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Lurasidone in Subjects 6 to 17 Years Old With Schizophrenia Spectrum, Bipolar Spectrum, Autistic Spectrum Disorder, or Other Psychiatric Disorders

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Lurasidone (Primary)
  • Indications Autistic disorder; Bipolar disorders; Psychotic disorders
  • Focus Pharmacokinetics
  • Sponsors Sunovion Pharmaceuticals

Most Recent Events

  • 26 Nov 2015 Results published in the Clinical Therapeutics
  • 01 May 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
  • 05 Dec 2012 Planned number of patients changed from 60 to 100 as reported by ClinicalTrials.gov.

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