Bioavailability Study of Anti Nausea Medication With and Without Food

NCT00905190 | Completed Phase 1

• 1 other identifier: ODO-P8-689
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

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

  1 dose on two separate days

Study Arms (2)

Fed

EXPERIMENTAL

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

Fasting

EXPERIMENTAL

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

Interventions

Ondansetron DRUG

24 mg one time

Also known as: EUR-1025

Fasting; Fed

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

Algorithme Pharma INc.

Mount Royal, Quebec, Canada

Location

MeSH Terms

Conditions

Nausea

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Eric Sicard, M.D.

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

CA (1)