The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
300 mg tablet
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Synergy Clinical Research Center
National City, California, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Global Medical Institutes/Princeton Medical Institute
Princeton, New Jersey, United States
bioequivalence determined by statistical comparison Cmax
Time frame: 10 days
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CRI Worldwide
Willingboro, New Jersey, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Claghorn-Lesem Research Clinic, Ltd
Houston, Texas, United States