NCT00649532

Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Ondansetron Tablets (24 mg; Mylan) and Zofran® Tablets (24 mg; GSK) 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 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron Tablets 24 mg	24mg, single dose fasting
DRUG	Zofran® Tablets 24 mg	24mg, single dose fasting

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States