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Study Evaluating and Comparing Single Dose and Multiple Dose Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Adults.

2014-08-27 03:27:29 | BioPortfolio

Summary

The purpose of the study was to evaluate and compare the pharmacokinetics of ER OROS paliperidone in healthy Japanese and Caucasian patients.

Description

This was a randomized (study medication assigned by chance), double blind (neither physician or patient knows the name of the study medication/placebo assigned) study comparing the single does (SD) and multiple dose (MD) pharmacokinetics of ER OROS paliperidone in 30 healthy Japanese and 30 healthy Caucasian adults.. The primary objectives of this study were to 1) evaluate the safety and tolerability of extended-release (ER) OROS paliperidone in healthy Japanese adults, 2) to evaluate the single dose (SD) and multiple dose (MD) pharmacokinetics of ER OROS paliperidone in healthy Japanese adults, and 3) to compare the SD and MD pharmacokinetics of ER OROS paliperidone in healthy Japanese and Caucasian adults. Of the 30 Japanese patients enrolled, at least 10 were to be men and 10 to be were women. An equal number of Caucasian patients, matched as closely as possible to the Japanese subjects for sex, age, and weight, were enrolled. Patients were randomly assigned to receive either ER OROS paliperidone or placebo (4:1 ratio). Blood samples for the determination of paliperidone enantiomer plasma concentrations were collected immediately prior to dosing on Days 1, 9, 10, 11, and 19, and at 2, 4, 6, 9, 12, 16, 18, 20, 22, 24, 27, 33, 36, 48, 58, 72, and 96 hours after dosing on Days 1, 11, and 19. Urine samples were collected predose and over 0-12, 12-24, 24-36, and 36-48 hour intervals after dosing on Days 1 and 19 and over 0-12 and 12-24 hour intervals after dosing on Day 11; a separate aliquot was taken from pooled 0-24 hour urine for urine creatinine concentration on Days 1, 11, and 19. Plasma and urine samples were analyzed using a validated LC-MS/MS method with a limit of quantification of 0.200 ng/mL and 1 ng/mL, respectively. The concentration of paliperidone in plasma and urine were calculated as the sum of the separate enantiomers. Based on the actual sampling times, the plasma and pharmacokinetic parameters were determined for paliperidone and its enantiomers.Safety evaluation was based on reports of adverse events, extrapyramidal symptoms (reported as adverse events or by Abnormal Involuntary Movement Scale [AIMS], Simpson Angus Scale [SAS], or Barnes Akathisia Rating Scale [BARS]), sedation (based on the Sedation Visual Analog Scale [VAS] and Sedation Questionnaire), and on change from baseline in clinical laboratory analyte values, vital sign measurements, orthostatic hypotension (based on the Orthostatic Hypotension Questionnaire), postural changes in blood pressure and heart rate, electrocardiograms, and physical examination findings. Paliperidone ER OROS tablet formulation (3 to 6 mg/day) to be taken orally. Patients were randomly assigned to receive either ER OROS paliperidone or placebo (4:1 ratio). All patients received a single dose of 3 mg ER OROS paliperidone (or placebo) on Day 1, a once daily regimen of 3 mg ER OROS paliperidone (or placebo) on Days 5 to 11, and a single dose of 6 mg ER OROS paliperidone (or placebo) on Day 19. All doses were administered in the fasted state.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Schizophrenia

Intervention

Paliperidone ER OROS

Status

Completed

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:27:29-0400

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A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia

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PubMed Articles [850 Associated PubMed Articles listed on BioPortfolio]

Hypersexuality Associated With Paliperidone: A Case Report.

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Evaluation of the Relative Abuse of an OROS® Extended-release Hydromorphone HCI Product: Results from three Post-market Surveillance Studies.

Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative...

One patient with schizophrenia showed reduced drug-induced extrapyramidal symptoms as a result of an alternative regimen of treatment with paliperidone 3 and 6 mg every other day.

Schizophrenia is a chronic disease that requires long-term management with antipsychotics. Antipsychotic drugs are given by tapering their dose, extending the dosing interval, and so on, as part of a ...

Genetic imaging study with Tc- TRODAT-1 SPECT in adolescents with ADHD using OROS-methylphenidate.

To examine theeffects on the brain of 2-month treatment withamethylphenidate extended-release formulation (OROS-MPH) using [Tc-] TRODAT-1SPECT in a sample of treatment-naïve adolescents with Attentio...

Medical and Biotech [MESH] Definitions

A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.

A type of schizophrenia characterized by frequent incoherence; marked loosening of associations, or grossly disorganized behavior and flat or grossly inappropriate affect that does not meet the criteria for the catatonic type; associated features include extreme social withdrawal, grimacing, mannerisms, mirror gazing, inappropriate giggling, and other odd behavior. (Dorland, 27th ed)

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