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Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder

NCT00501618 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-15

No results posted yet for this study

Summary

The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.

Conditions

Interventions

DRUG

Fazaclo

single-arm

Sponsors & Collaborators

  • Azur Pharma, Inc

    collaborator INDUSTRY

  • Manhattan Psychiatric Center

    lead OTHER

Principal Investigators

  • Jean-Pierre Lindenmayer, MD · Manhattan Psychiatric Center

  • Saurabh Kaushik, MD · Nathan Kline Institute & Manhattan Psychiatric Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-03-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00501618 on ClinicalTrials.gov