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

Roxane Laboratories

Status

Completed

Conditions

Bipolar I Disorder

Treatments

Drug: Quetiapine Fumarate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01570959

QUET-T300-PVSS

Details and patient eligibility

About

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

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.