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A Bioequivalence Study of 15 mg ER OROS Paliperidone

NCT00892489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-06-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the effect of food on the highest to be marketed tablet strength. Additionally, the safety and tolerability of the treatments in healthy volunteers will be assessed.

Conditions

Interventions

DRUG

ER OROS Paliperidone

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Completion
2004-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00892489 on ClinicalTrials.gov