NCT00648804

Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg

Single-Dose Food In Vivo Bioequivalence Study of Ondansetron Orally Disintegrating Tablets (8 mg; Mylan) to Zofran ODT® Tablets (8 mg; GlaxoSmithKline) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron Orally Disintegrating Tablets 8 mg	8mg, single dose fed
DRUG	Zofran ODT® Tablets 8 mg	8mg, single dose fed

Timeline

• Start date: 2005-07-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States