Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

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 non-fasting conditions in healthy, non-smoking, adult subjects.

Timeline

Start

2003-02

Primary completion

2003-02

Completion

2003-02

Outcome

Met primary endpoint

registry Ratio of Geometric Means 97.1 (90% CI 91.2 to 103) NCT00934921 ↗

registry Ratio of Geometric Means 95.2 (90% CI 88.8 to 102) NCT00934921 ↗

registry Ratio of Geometric Means 95.9 (90% CI 89.5 to 103) NCT00934921 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ondansetron	Other / unclassified	8 mg	—

Indications

No indication recorded.