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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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