Phase 1
Completed N=45
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Source: ClinicalTrials.gov NCT00972595 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
Jun 2010
Primary outcomePrimary: Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron — 257.8; 262.6 ng*hr/mL
Summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron |
257.8; 262.6 | — |
| PRIMARY Peak Plasma Concentration (Cmax) for Ondansetron |
41.3; 41.8 | — |
Eligibility Criteria
Inclusion Criteria
- If female, subject is not pregnant or breast-feeding
- Subject has been a nonsmoker for at least 6 months
- Subject is in good health
Exclusion Criteria
- Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease
- Subject is a habitual and heavy consumer of caffeine
Data sourced from ClinicalTrials.gov (NCT00972595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.