Bioavailability Study of Anti Nausea Medication With and Without Food (EUR-1025)

February 8, 2017 updated by: Forest Laboratories

Single Dose Crossover Comparative Bioavailability Study To Assess the Effect of Food on the Pharmacokinetics of Ondansetron Modified-Release Capsules (EUR1025) in Healthy Male and Female Volunteers

This study is to assess the effect of food on a single dose of EUR-1025 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 assess the effect of food on the pharmacokinetics of a single 24 mg dose of EUR-1025 administered as a novel modified-release capsule formulation under fed and fasting conditions.

Study Type

Interventional

Enrollment (Actual)

22

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
        • 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,
  • Of at least 21 years of age but not older than 55 years with a body mass index targeted to be at least 18.5 and less than 30 kg/m2,
  • Healthy, normal lab values,
  • Negative HIV, Hepatitis B & C and a negative ethyl alcohol and drug screen,
  • Normal 12 lead ECG, negative human chorionic gonadotropin (hCG) for females.

Exclusion Criteria:

  • No known hypersensitivity to Ondansetron or any related products,
  • Presence of significant gastrointestinal, liver or kidney disease,or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects,
  • History of significant gastrointestinal, liver or kidney disease,
  • Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease,
  • Suicidal tendency,
  • History of or disposition to seizures, state of confusion, clinically relevant psychiatric disease,
  • Presence of significant heart disease or disorder discovered on screening ECG,
  • Females who are found to have a positive serum pregnancy test at screening or are nursing,
  • Females of childbearing potential who refuse to use an acceptable contraceptive regimen from the screening visit and throughout the study,
  • Maintenance therapy with any drug,
  • Significant history of drug dependency or alcohol abuse (> 2 units of alcohol per day, intake of excessive alcohol, acute or chronic),
  • Any clinically significant illness in the previous 28 days before day 1 of the study,
  • Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,fluconazole, ketoconazole,diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study,
  • Volunteers who took an 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,
  • Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately,
  • Inability to understand and to observe the instructions of the physician,
  • Donation of 500 ml or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies) in the previous 56 days before day 1 of this study,
  • Positive urine screening of drugs or abuse,
  • Any history of tuberculosis and/or prophylaxis for tuberculosis,
  • Positive results to HIV, HBsAg, or anti-HCV tests,
  • No subjects will be allowed to enroll in this study more than once.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fed
A single oral dose of ondansetron (1 x 24 mg) will be administered with approximately 240 ml of water in the morning. The ondansetron dose will be administered after a 10-hour overnight fast and thirty minutes after consuming a high-fat, high-caloric breakfast
Drug: Ondansetron
24 mg one time
Other Names:
  • EUR-1025
Experimental: Fasting
A single oral dose of ondansetron (1 x 24 mg) will be administered with approximately 240 ml of water in the morning after a 10-hour overnight fast.
Drug: Ondansetron
24 mg one time
Other Names:
  • EUR-1025

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of food on the pharmacokinetics of a single 24 mg dose of ondansetron administered under fed and fasting conditions
Time Frame: 1 dose on two separate days
1 dose on two separate 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)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODO-P8-689

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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