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Clinical Trial 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.


Clinical Trial Description

This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.

Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water

Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water ;


Study Design


Related Conditions & MeSH terms

  • Nausea
  • Nausea and Vomiting, Postoperative
  • Nausea With Vomiting Chemotherapy-Induced
  • Postoperative Nausea and Vomiting
  • Vomiting

NCT number NCT01217190
Study type Interventional
Source Aquestive Therapeutics
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 16, 2008
Completion date October 6, 2008

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