Phase 1
Completed N=12
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Source: ClinicalTrials.gov NCT00971633 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron — 644; 712; 649 nM*hr
Summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron |
644; 712; 649 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Ondansetron |
82; 93; 86 | — |
Eligibility Criteria
Inclusion Criteria
- If female, subject is not pregnant or breast-feeding
- Subject is a nonsmoker
- Subject is in good general health
Exclusion Criteria
- Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
- Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
- Subject is a habitual and heavy consumer of caffeine
Data sourced from ClinicalTrials.gov (NCT00971633). 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.