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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01036854

Enrollment

128

Registered

2009-12-21

Start date

2009-02-28

Completion date

2009-04-30

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea

Keywords

Ondansetron, EUR-1025

Brief 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.

Interventions

DRUGEUR-1025

orally, 24 mg, daily for 6 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Male and female volunteers * Non- or ex-smokers * At least 21 years of age but not older than 55 years * Body mass index targeted to be at least 18.5 and less than 30 kg/m2. * Acceptable lab tests * Normal 12 lead ECG * Negative human chorionic gonadotropin (hCG) for females.

Exclusion criteria

* No known hypersensitivity to Ondansetron or any related products * No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption * No presence of significant heart disease or disorder discovered on screening ECG * Not pregnant * No alcohol or drug abuse history * No use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) * No previous Investigational Product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study

Design outcomes

Primary

Measure	Time frame
Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.	6 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026