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Intermediate release Paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Intermediate release Paliperidone · 1 trial · 2 indications

Phase 1 1
NCT00791284A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver FunctionSchizophrenia
COMPLETED20 Analytics
PHASE1COMPLETED
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate the single-dose pharmacokinetics of IR paliperidone after oral administration to patients with moderate hepatic impairment as compared to patients with normal hepatic function

Secondary Endpoints

To document the plasma protein binding and disposition of the enantiomers of paliperidone and to evaluate the tolerability and safety profile of IR paliperidone in both patient populations
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Intermediate release (IR) PaliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Patients with normal hepatic function:Normotensive at screening, with supine (5 minutes) blood pressure between the range of 95 to 160 mmHg systolic, inclusive, and 55 to 95 mmHg diastolic, inclusive, demographically comparable to the hepatic impairment group with respect to a...

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Frequently asked questions about Intermediate release Paliperidone

What is Intermediate release Paliperidone used for?

Intermediate release Paliperidone is an investigational small molecule being studied for the treatment of schizophrenia. It is in Phase 1 clinical development. The drug is being evaluated in a pharmacokinetic study involving volunteers with normal or impaired liver function, with the condition of schizophrenia listed as a study condition.

Who makes Intermediate release Paliperidone?

Intermediate release Paliperidone is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development for the treatment of schizophrenia.

What phase is Intermediate release Paliperidone in?

Intermediate release Paliperidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains in early-stage clinical development for schizophrenia.

What clinical trials is Intermediate release Paliperidone in?

Intermediate release Paliperidone has one completed clinical trial, identified as NCT00791284. This Phase 1 study, titled 'A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function,' enrolled 20 participants and included healthy volunteers. The study was uncontrolled and not randomized or double-blinded.

Is Intermediate release Paliperidone the same as Paliperidone?

Intermediate release Paliperidone is a formulation of paliperidone, an antipsychotic medication. The drug is being developed by Johnson & Johnson for schizophrenia. The clinical trial NCT00791284 specifically studies the pharmacokinetics of paliperidone in volunteers with normal or impaired liver function.