NCT00981487

Bioavailability Study of Anti Nausea Medication With and Without Food (EUR-1025)

Single-Dose Crossover Comparative Bioavailability Study to Assess the Effect of Food on the Pharmacokinetics of Ondansetron Modified-Release Capsules (EUR-1025) in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the effect of food on a single dose of Ondansetron when taken with a meal on an empty stomach.

Detailed description

The objective of this study is to assess the effect of food on the pharmacokinetics of a single 24 mg dose of Ondansetron administered as a novel modified-release capsule formulation under fed and fasting conditions.

Conditions

• Nausea

Interventions

Type	Name	Description
DRUG	Ondansetron	24 mg one time
DRUG	Ondansetron	24 mg, on time in the am

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-09-22
• Last updated: 2017-02-09