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Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving Filmstrip 8mg With Zofran Orally Disintegrating Tablets in 48 Participants Under Fed Conditions

Bioavailability Clinical Trial

Official title:
An Open-label Randomized, Single Oral Dose, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip (ODFS) 8mg (Manufactured by MonoSol Rx, USA) With Zofran Orally Disintegrating Tablets [ODT® (Containing Ondansetron 8 mg)] (Manufactured by Cardinal Health Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo SmithKline, Research Triangle Park, NC 27709, Made in England) in 48 Healthy, Adult, Human Study Participants Under Fed Conditions.

Clinical Trial Summary

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg) (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female adult, human study participants under fed conditions.

• To monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

Clinical Trial Description

n/a

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01217801
Study type Interventional
Source Par Pharmaceutical, Inc.
Contact
Status Completed
Phase Phase 3
View Details
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