Clinical trial NCT01570959: Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions
Official title: A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar I Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Princeton
country: United States
facility: Global Medical Institutes/Princeton Medical Institute
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Ltd
state: Texas
Study officials:
References: