Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
Not Applicable
Completed
- Conditions
- Treatment for Bipolar I Disorder
- Registration Number
- NCT01570907
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 15 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Houston, Texas, United States
Novum Pharmaceutical Research Services🇺🇸Houston, Texas, United States