NCT00654277

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions

Comparative, Randomized, Single-Dose, Cross Over Bioavailability of Kali's Ondansetron 8 mg ODT With That of GlaxoSmithKine's Zofran 8 mg ODT in Healthy, Male and Female Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (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 8 mg oDT and Zofran 8 mg ODT

Detailed description

To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of GlaxoSmithKine's Zofran 8 mg ODT under fasting conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron	ODT, 8 mg, single-dose
DRUG	Zofran	ODT, 8 mg, fasting 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