NCT01217801

Two Way Bioequivalence Study Under Fed Conditions

Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: MonoSol Rx · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

Detailed description

An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets \[ODT® (Containing Ondansetron 8 mg)\] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ondansetron (ODFS)	Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
DRUG	Ondansetron (ODT)	Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2010-10-08
• Last updated: 2017-05-02
• Results posted: 2017-05-02

Locations

1 site across 1 country: India