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

2014-08-27 03:17:07 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Nausea

Intervention

EUR-1025, EUR-1025, EUR-1025, EUR-1025

Location

Algorithme Pharma INc.
Mount-Royal
Quebec
Canada
H3P 3PI

Status

Completed

Source

Eurand S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:07-0400

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