NCT00934921

Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron	1 x 8 mg Orally Disintegrating Tablet
DRUG	Zofran®	1 x 8 mg ODT

Timeline

• Start date: 2003-02-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2009-07-08
• Last updated: 2024-08-21
• Results posted: 2009-08-25

Locations

1 site across 1 country: United States