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

February 8, 2017 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Mount-Royal, Quebec, Canada, H3P 3PI
        • Algorithme Pharma Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regime 1
Regime 1 will be orally administered once daily in the morning over 6 consecutive days.
Drug: EUR-1025
orally, 24 mg, daily for 6 days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, twice daily over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, three times a day over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Other Names:
  • Ondansetron
Active Comparator: Regime 2
Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days
Drug: EUR-1025
orally, 24 mg, daily for 6 days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, twice daily over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, three times a day over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Other Names:
  • Ondansetron
Active Comparator: Regime 3
Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days.
Drug: EUR-1025
orally, 24 mg, daily for 6 days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, twice daily over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, three times a day over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Other Names:
  • Ondansetron
Experimental: Regime 4
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
orally, 24 mg, daily for 6 days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, twice daily over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, three times a day over 6 consecutive days
Other Names:
  • Ondansetron
Drug: EUR-1025
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Other Names:
  • Ondansetron

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODO-P8-690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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