Overview

Two Way Bioequivalence Study Under Fed Conditions

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
MonoSol Rx
Par Pharmaceutical, Inc.
Collaborator:
MonoSol Rx
Treatments:
Ondansetron