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IR OROS paliperidone and OROS paliperidone · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| IR OROS paliperidone and ER OROS paliperidone | DRUG | - |
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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IR OROS paliperidone is an investigational small molecule studied for schizophrenia. It was evaluated in a Phase 1 trial that examined how the paliperidone enantiomer is handled by the body when delivered through different formulations. The program is being developed by Johnson & Johnson, which trades under the ticker JNJ.
Johnson & Johnson, ticker JNJ, is the developer of IR OROS paliperidone. The company sponsored the clinical work evaluating this small molecule formulation for schizophrenia. Johnson & Johnson is a large healthcare company whose pharmaceutical business covers several therapeutic areas, including psychiatry.
IR OROS paliperidone is in Phase 1 clinical development for schizophrenia. The single recorded trial, NCT00796276, is a completed Phase 1 study. It is an investigational agent and is not an approved product. The study enrolled 20 participants, including healthy volunteers, and used a randomized design.
NCT00796276 is the Phase 1 trial of IR OROS paliperidone. Titled "A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release Paliperidone," it enrolled 20 participants aged 18 years and older of any sex. The trial is completed and focused on schizophrenia.
IR OROS paliperidone and ER OROS paliperidone are related names for paliperidone formulations, with IR denoting immediate release and ER denoting extended release. The Phase 1 trial NCT00796276 compared the disposition of the paliperidone enantiomer across different formulations and assessed the bioavailability of immediate-release and extended-release paliperidone.
Twenty participants were enrolled in NCT00796276, the Phase 1 trial of IR OROS paliperidone. The study was randomized and included healthy volunteers aged 18 years and older, with both sexes eligible. It examined paliperidone enantiomer disposition across formulations and the bioavailability of immediate-release and extended-release paliperidone in schizophrenia research.