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An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2004-06 |
| Completion | 2004-09 |
Conditions
- Chemotherapy-Induced Nausea and Vomiting
Interventions
- ondansetron clinical trial formulation
- ondansetron marketed formulation
Primary outcomes
- Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron — 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose
- Peak Plasma Concentration (Cmax) for Ondansetron — 24 hours post-dose