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A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal Consta at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder

Trial Profile

A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal Consta at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 May 2019

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At a glance

  • Drugs Risperidone (Primary)
  • Indications Schizoaffective disorder; Schizophrenia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Luye Pharma Group
  • Most Recent Events

    • 29 May 2019 According to a Luye Pharma Group media release, the US Food and Drug Administration (FDA) has completed the filing review and accepted the filing of Rykindo's new drug application (NDA).
    • 28 Mar 2019 According to a Luye Pharma Group media release, based on the data of this study and two other supportive studies, the company has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for Risperidone Extended Release Microspheres for Injection (LY03004) for the treatment of schizophrenia and/or schizoaffective disorders.
    • 30 Dec 2018 According to a Luye Pharma Group media release, based on the data of this study, the company has entered the final stage of New Drug Application (NDA) submissions to the US FDA for Risperidone Extended Release Microspheres for Injection (LY03004) for the treatment of schizophrenia and/or schizoaffective disorders, after previous positive pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and subsequent related procedures.
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