Phase 1
N=12
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Chemotherapy-Induced Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00971633 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron — 644; 712; 649 nM*hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Comparator: Treatment A (Zofran, ondansetron) (Drug); Comparator: Treatment B (Zofran, ondansetron) (Drug); Comparator: Treatment C (Zofran, ondansetron) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2003
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 | — |
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.
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.