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Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.

NCT00645502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-04-26

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the bioequivalence, with respect to risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg orally-disintegrating tablet and as a 4 mg conventional RISPERDAL tablet. In addition, their tolerability and safety will be documented.

Conditions

Interventions

DRUG

risperidone

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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Completion
2003-07-31

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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 NCT00645502 on ClinicalTrials.gov