Back to resultsCrossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Primary Purpose
Bipolar I Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quetiapine Fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I Disorder
Eligibility 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.
Sites / Locations
- Novum Pharmaceutical Research Services
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01570894
Brief Title
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Other Intervention Name(s)
Seroquel
Intervention Description
25 mg tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
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