Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-06 @ 10:19 AM
Study NCT ID:
NCT00501618
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2007-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder
Sponsor:
Manhattan Psychiatric Center
Organization:
Study Overview
Official Title:
An Open-Label Study Changing Generic Clozapine Formulation to FazaClo® (Clozapine, USP) Orally Disintegrating Tablets in Stable Patients With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The primary objective of this study is to determine the equivalence of generic clozapine tablets to FazaClo in patients with schizophrenia or schizoaffective disorder who are already taking generic clozapine and are switched to FazaClo.
In this study, patients receiving a stable twice-daily dose of generic clozapine formulation for the past one month will be switched to FazaClo. A trough steady-state clozapine and desmethylclozapine concentrations will be taken thrice while patient is on generic Clozapine. After the third clozapine level patients will be switched from their generic clozapine formulation to FazaClo, at the same dosage and treatment regimen as the generic clozapine formulation they had been receiving. Trough steady-state clozapine and desmethylclozapine concentration levels will be taken twice, 7 days and 14 days after starting Fazaclo.
In this study, patients receiving a stable twice-daily dose of generic clozapine formulation for the past one month will be switched to FazaClo. A trough steady-state clozapine and desmethylclozapine concentrations will be taken thrice while patient is on generic Clozapine. After the third clozapine level patients will be switched from their generic clozapine formulation to FazaClo, at the same dosage and treatment regimen as the generic clozapine formulation they had been receiving. Trough steady-state clozapine and desmethylclozapine concentration levels will be taken twice, 7 days and 14 days after starting Fazaclo.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: