NCT01036854

Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)

Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.

Detailed description

The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.

Conditions

• Nausea

Interventions

Type	Name	Description
DRUG	EUR-1025	orally, 24 mg, daily for 6 days
DRUG	EUR-1025	orally, 8 mg, twice daily over 6 consecutive days
DRUG	EUR-1025	orally, 8 mg, three times a day over 6 consecutive days
DRUG	EUR-1025	orally, 8 mg, 16 mg, 24 mg, daily, for 6 days

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-12-21
• Last updated: 2017-02-09

Locations

1 site across 1 country: Canada