Study Seeking Patients with Schizophrenia

  • STATUS
    Recruiting
  • sponsor
    TEVA
Updated on 8 November 2020

Summary

Study Seeking Patients with Schizophrenia

Description

A Randomized, Open-label, Multiple-dose, Parallel Design, Comparative Bioequivalence Study of Paliperidone Palmitate Extended-Release Injectable Suspension (156 mg/1.0 mL) Versus Invega Sustenna® (paliperidone palmitate) Extended-Release Injectable Suspension (156mg/1.0 mL) in Schizophrenia Patients Already Stabilized on Paliperidone Palmitate

Details
Clinical Study IdentifierTX148352
SponsorTEVA
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Males and females 18-65 years of age
Body mass index of 18.0-38.0 kg/m2 inclusive
Patients must not have been either hospitalized for worsening of schizophrenic symptoms or judged by the investigator as having significant exacerbation of schizophrenic symptoms during the 3 months prior to screening
Patients must have an identified support person
Patients must have a stable place of residence for the 3 months prior to screening

Exclusion Criteria

Have a known hypersensitivity to paliperidone, risperidone, or to any excipients in the Formulation
Patients with a history of or who are currently diagnosed as having epilepsy or convulsion Disorders
Patients who have a history of malignancy within the past five years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)
Current heavy smoking, defined as smoking > 2 packs of cigarettes (or 5 cigars) per day for 1 year or greater
Patients who have received an investigational drug as part of a clinical trial within 30 days prior to screening or current participation in another clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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