Last reviewed · How we verify
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.
Details
| Lead sponsor | Roxane Laboratories |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 42 |
| Start date | 2007-06 |
| Completion | 2007-07 |
Conditions
- Treatment for Bipolar I Disorder
Interventions
- Quetiapine Fumarate
Primary outcomes
- bioequivalence determined by statistical comparison Cmax — 15 days
Countries
United States