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IR OROS paliperidone and OROS 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

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

IR OROS paliperidone and OROS paliperidone · 1 trial · 1 indication

Phase 1 1
NCT00796276A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release PaliperidoneSchizophrenia
COMPLETED20 Analytics
PHASE1COMPLETED
A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release Paliperidone
Schizophrenia
NCT0079627620
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Study Endpoints

Primary Endpoints

To characterize and document the pharmacokinetics of paliperidone in plasma and urine;the (+) and (-) paliperidone ratio;the possible interconversion between the (+)- and (-)- enantiomers of paliperidone;the absolute oral bioavailability of paliperidone

Secondary Endpoints

To document the possible relationship between the volunteer's CYP2D6 phenotype and the disposition of the (+) and (-) enantiomers of paliperidone and to evaluate the safety and tolerability of the treatments in healthy volunteers
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
IR OROS paliperidone and ER OROS paliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Known dextromethorphan (i.e., previously determined) metabolic ratio of \<0.02 or \>0.35, as determined according to the standard procedures of the study center * Acceptable weight as defined by body mass index (weight \[kg\]/height \[m²\]) range of 18 to 28 kg/m², inclusive *...

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Competitive Landscape -Schizophrenia 36 trials

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY8PHASE3KarXT
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
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Frequently asked questions about IR OROS paliperidone and OROS paliperidone

What is IR OROS paliperidone and OROS paliperidone used for?

IR OROS paliperidone and OROS paliperidone are investigational small molecules being studied for the treatment of schizophrenia. They are developed by Johnson & Johnson (JNJ). The drug is currently in Phase 1 clinical development, meaning it is not yet approved and is still being evaluated in clinical trials.

Who makes IR OROS paliperidone and OROS paliperidone?

Johnson & Johnson (JNJ) is developing IR OROS paliperidone and OROS paliperidone. The company is conducting clinical research on this investigational small molecule for schizophrenia. As of the latest data, the drug is in Phase 1 development.

What phase is IR OROS paliperidone and OROS paliperidone in?

IR OROS paliperidone and OROS paliperidone are in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied for schizophrenia, with one completed Phase 1 trial involving 20 participants.

What clinical trials is IR OROS paliperidone and OROS paliperidone in?

IR OROS paliperidone and OROS paliperidone have one completed clinical trial, NCT00796276, titled 'A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release Paliperidone.' This Phase 1 study enrolled 20 participants with schizophrenia and was uncontrolled.

Is IR OROS paliperidone the same as OROS paliperidone?

IR OROS paliperidone and OROS paliperidone are two formulations of the same drug, paliperidone, studied together in clinical trials. The 'IR' denotes immediate-release, while 'OROS' refers to the extended-release osmotic system. Both are being developed by Johnson & Johnson for schizophrenia.