Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions

Bipolar I Disorder Clinical Trial

Official title:

A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570959
• Other study ID #: QUET-T300-PVSS
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: January 19, 2018
• Start date: April 2007
• Est. completion date: November 2007

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Stable patients with the DSM-IV TR diagnosis of schizophrenia. These patients are to be identified via psychiatric evaluation and meet DSM-IV TR criteria for schizophrenia of paranoid (295.30), disorganized (295.10), catatonic (295.20), undifferentiated (295.90), or residual (295.60) subtype.

2. Patient to have no significant breakthrough symptoms or exacerbations of psychiatric illness necessitating hospitalization in the 3 months prior to screening.

3. Patient to have a CGI-S score of 3 or less at screening.

4. On a stable regimen of treatment to include quetiapine fumarate for 3 months minimum prior to screening, and on a dose of quetiapine fumarate totaling 600 mg total per day for a minimum of 1 month prior to screening. Patients who are on qd dosing of daily quetiapine fumarate must be willing to convert to 300 mg bid dosing for the duration of the study.

Exclusion Criteria:

1. All other DSM-IV axis I diagnoses, including schizoaffective disorder, schizophreniform disorder and/or any other psychiatric diagnoses that in the opinion of the principal investigator may during the conduct of the trial become a primary treatment concern, or may interfere in the patients ability to participate in the trial.

2. Positive test for HIV, Hepatitis B, or Hepatitis C.

3. Treatment with known enzyme altering drugs.

4. History of allergic or adverse response to quetiapine or any comparable or similar product.

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• Quetiapine Fumarate
300 mg tablet

Locations

Country	Name	City	State
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Claghorn-Lesem Research Clinic, Ltd	Houston	Texas
United States	Synergy Clinical Research Center	National City	California
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Global Medical Institutes/Princeton Medical Institute	Princeton	New Jersey
United States	CRI Worldwide	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		10 days