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
1 other identifier
interventional
42
1 country
1
Brief Summary
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 28, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedJanuary 23, 2018
January 1, 2018
1 month
March 28, 2012
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
bioequivalence determined by statistical comparison Cmax
15 days
Interventions
Eligibility Criteria
You may qualify if:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novum Pharmaceutical Research Services
Houston, Texas, 77042, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2012
First Posted
April 4, 2012
Study Start
June 1, 2007
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
January 23, 2018
Record last verified: 2018-01