NCT00653458

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

Comparative, Randomized, Single-Dose, Cross Over Bioavailability Study of Kali's Ondansetron ODT 8 mg With That of GlaxoSmithKine's Zofran ODT 8 mg in Healthy Adult Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg

Detailed description

To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron	ODT, 8 mg, single-dose, fed conditions
DRUG	Zofran	ODT, 8 mg, single-dose, under fed conditions

Timeline

• Start date: 2002-08-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2008-04-07
• Last updated: 2008-04-11