drugset / Trial / NCT01217190

Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

NCT01217190

Phase 1/2 Completed 48 enrolled MonoSol Rx
RandomizedCrossoverOpen-labelOther

Summary

This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.

Timeline

Start
2008-09-16
Primary completion
2008-09-26
Completion
2008-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ondansetron Other / unclassified 8 mg Oral