Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants

NCT01220167 Phase 1 COMPLETED Results posted

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

Details

Lead sponsor	Aquestive Therapeutics
Phase	Phase 1
Status	COMPLETED
Enrolment	18
Start date	2008-08
Completion	2008-08

Conditions

• Healthy Participants

Interventions

• Ondansetron 8 mg ODFS without water
• Ondansetron 8 mg ODFS with water
• Zofran ODT (ondansetron 8 mg) without water

Primary outcomes

• Cmax — 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
  Maximum Plasma Concentration (Time to reach maximum concentration)
• AUCt — 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
  Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")
• AUCinf — 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
  Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity