drugset / Trial / NCT00934180
Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions
RandomizedCrossoverOpen-labelOther
Summary
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.
Timeline
- Start
- 2002-12
- Primary completion
- 2002-12
- Completion
- 2002-12
Outcome
Met primary endpoint
registry analysis (unspecified test); Ondansetron vs Zofran®; Ratio of Geometric Means 103 (90% CI 95.1 to 111) NCT00934180 ↗
registry analysis (unspecified test); Ondansetron vs Zofran®; Ratio of Geometric Means 101 (90% CI 95.3 to 107) NCT00934180 ↗
registry analysis (unspecified test); Ondansetron vs Zofran®; Ratio of Geometric Means 101 (90% CI 95.2 to 108) NCT00934180 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ondansetron | Other / unclassified | 8 mg | Oral |
Indications
No indication recorded.