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

Primary Purpose

Nausea

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Algorithme Pharma INc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fed

Fasting

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Effects of food on the pharmacokinetics of a single 24 mg dose of ondansetron administered under fed and fasting conditions

Secondary Outcome Measures

Full Information

First Posted
May 18, 2009
Last Updated
February 8, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00905190
Brief Title
Bioavailability Study of Anti Nausea Medication With and Without Food
Acronym
EUR-1025
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fed
Arm Type
Experimental
Arm Description
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
Arm Title
Fasting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
EUR-1025
Intervention Description
24 mg one time
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sicard, M.D.
Organizational Affiliation
Algorithme Pharma Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algorithme Pharma INc.
City
Mount-Royal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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Bioavailability Study of Anti Nausea Medication With and Without Food

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