A randomized, single dose, balanced, multicenter, three-treatment, single period, parallel group, comparative bioavailability study of Paliperidone Intramuscular Injection

Wockhardt Limited0 个研究点目标入组 18 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Written informed consent for participation in the study by the patient and patientâ??s legal acceptable representative (LAR).
•2) Schizophrenic patients between 18.0 years and above.
•3) Patients who are stabilized on Paliperidone extended release tablet 9mg once a day (atleast 8 consecutive doses before IP administration).
•4) Patients have a documented clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as confirmed by the investigator.
•5) Not having any significant diseases or clinical significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluation, which may prevent to administer Paliperidone or Resperidone.
•6) Able to comply with study procedures in the opinion of the investigator.

•1) Current or relevant history of serious, severe or unstable psychiatric illness except schizophrenia.
•2) History of neuroleptic malignant syndrome, tardive dyskinesia, or any malignancy.
•3) Elderly patients with dementia-related psychosis treated with antipsychotic drugs
•4) Patient on different antipsychotic treatment and unable to shift on Paliperidone oral therapy.
•5) Have a DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence.
•6) Be involuntarily-hospitalized or plan to undergo surgery/procedures during the course of the study
•7) Patient has taken the following prohibited medications: Strong CYP3A4/P-glycoprotein (P-gp) inducers (e.g., carbamazepine, rifampin, St Johnâ??s wort) barbiturates within 14 days prior to randomization.
•8) Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
•9) Patient with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
•10) Personal / family history of allergy or hypersensitivity to Paliperidone or risperidone or its congeners or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator would compromise the safety of the patient or the study.
•11) Evidence of impairment of renal, hepatic, cardiac, lungs or gastrointestinal function.

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