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

NCT01570959 | Completed

• 1 other identifier: QUET-T300-PVSS
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• bioequivalence determined by statistical comparison Cmax

  10 days

Interventions

Quetiapine Fumarate DRUG

300 mg tablet

Also known as: Seroquel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Patient to have no significant breakthrough symptoms or exacerbations of psychiatric illness necessitating hospitalization in the 3 months prior to screening.
• Patient to have a CGI-S score of 3 or less at screening.
• 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.

You may not qualify if:

• 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.
• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to quetiapine or any comparable or similar product.

Sponsors & Collaborators

• Roxane Laboratories: lead

Study Sites (7)

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Global Medical Institutes/Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

CRI Worldwide

Willingboro, New Jersey, 08046, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

Claghorn-Lesem Research Clinic, Ltd

Houston, Texas, 77008, United States

Location

MeSH Terms

Interventions

Quetiapine Fumarate

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (7)