Overview

Bioavailability Study of Anti Nausea Medication With and Without Food

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Ondansetron
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.