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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01570907
First received: March 28, 2012
Last updated: April 2, 2012
Last verified: April 2012

March 28, 2012
April 2, 2012
June 2007
July 2007   (final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01570907 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Treatment for Bipolar I Disorder
Drug: Quetiapine Fumarate
25 mg tablet
Other Name: Seroquel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2007
July 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01570907
QUET-T25-PVFS-2
No
Roxane Laboratories
Roxane Laboratories
Not Provided
Not Provided
Roxane Laboratories
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP