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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nausea

Intervention / Treatment
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* Drug: EUR-1025
* Drug: EUR-1025
* Drug: EUR-1025
* Drug: EUR-1025


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regime 1<br>Regime 1 will be orally administered once daily in the morning over 6 consecutive days. | Drug: EUR-1025<br>* orally, 24 mg, daily for 6 days<br>* Other names: Ondansetron;|
| Active Comparator: Regime 2<br>Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days | Drug: EUR-1025<br>* orally, 8 mg, twice daily over 6 consecutive days<br>* Other names: Ondansetron;|
| Active Comparator: Regime 3<br>Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days. | Drug: EUR-1025<br>* orally, 8 mg, three times a day over 6 consecutive days<br>* Other names: Ondansetron;|
| Experimental: Regime 4<br>Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 & 5- two placebo capsules on each day; Day 6- a single does will be given. | Drug: EUR-1025<br>* orally, 8 mg, 16 mg, 24 mg, daily, for 6 days<br>* Other names: Ondansetron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay. |  | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ondansetron, EUR-1025