NCT00934180

Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions

A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under 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 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: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2009-07-08
• Last updated: 2024-08-21
• Results posted: 2009-08-25

Locations

1 site across 1 country: United States