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

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


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.


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




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


Algorithme Pharma INc.




Eurand S.p.A.

Results (where available)

View Results


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

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