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Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01570907
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Brief Summary:
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.

Condition or disease Intervention/treatment Phase
Treatment for Bipolar I Disorder Drug: Quetiapine Fumarate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions
Study Start Date : June 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Quetiapine Fumarate
    25 mg tablet
    Other Name: Seroquel


Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570907


Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01570907     History of Changes
Other Study ID Numbers: QUET-T25-PVFS-2
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs