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

Nausea Clinical Trial

— ODO-P8-689  

Official title:

Single-Dose Crossover Comparative Bioavailability Study to Assess the Effect of Food on the Pharmacokinetics of Ondansetron Modified-Release Capsules (EUR-1025) in Healthy Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981487
• Other study ID #: EUR-1025
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2009
• Last updated: February 8, 2017
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: February 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to assess the effect of food on a single dose of Ondansetron when taken with a meal on an empty stomach.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• male and female volunteers,

• non or ex-smokers,

• at least 21 years of age but not older than 55 years,

• a body mass index targeted to be at least 18.5 and less than 30 kg/m2

• healthy,

• acceptable normal lab tests,

• negative HIV, Hepatitis B and C,

• a negative ethyl alcohol and drug screen,

• normal 12 lead ECG, AND

• 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, OR

• positive results to HIV, HBsAg, or anti-HCV tests.

• no subject will be allowed to enroll in this study more than once.

Related Conditions & MeSH terms

• Nausea

Intervention

Drug:
• Ondansetron
24 mg one time
• Ondansetron
24 mg, on time in the am

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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