Last reviewed · How we verify
A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under 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 fasting conditions in healthy, non-smoking adult subjects.
Details
| Lead sponsor | Teva Pharmaceuticals USA |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2002-12 |
| Completion | 2002-12 |
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