Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | July 2007 |
| End Date: | July 2007 |
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories'
Quetiapine Fumarate 25 mg Tablet under fed conditions.
Quetiapine Fumarate 25 mg Tablet under fed conditions.
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.
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