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A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Non-Fasting Conditions
The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking, adult subjects.
Details
| Lead sponsor | Teva Pharmaceuticals USA |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2003-02 |
| Completion | 2003-02 |
Conditions
- Healthy
Interventions
- Ondansetron
- Zofran®
Primary outcomes
- Cmax - Maximum Observed Concentration — Blood samples collected over 24 hour period
Bioequivalence based on Cmax - AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) — Blood samples collected over 24 hour period
Bioequivalence based on AUC0-inf - AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) — Blood samples collected over 24 hour period
Bioequivalence based on AUC0-t
Countries
United States