Bioavailability Study of Anti Nausea Medication With and Without Food (EUR-1025) (ODO-P8-689)
This study has been completed.
Information provided by:
First received: September 21, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
This study is to assess the effect of food on a single dose of Ondansetron when taken with a meal on an empty stomach.
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Effects of food on the pharmacokinetics of a single 24 mg dose of ondansetron administered under fed abd fasting conditions [ Time Frame: 1 dose on two separate days ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
A single oral dose of EUR-1025 (1x24 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.
24 mg one time
Other Name: EUR-1025
A single oral dose of EUR-1025 (1x 24 mg) will be administered with approximately 240 ml of water in the morning after a 10-hour overnight fast.
24 mg, on time in the am
Other Name: EUR-1025
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.
|Ages Eligible for Study:
||21 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- acceptable normal lab tests,
- negative HIV, Hepatitis B & C,
- a negative ethyl alcohol and drug screen,
- normal 12 lead ECG, AND
- negative HCG for females.
- 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, dilitiazem 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981487
||Eric Sicard, M.D.
||Algorithme Pharma Inc
No publications provided
||Ruth Thieroff-Ekerdt, M.D., Eurand Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 21, 2009
||September 21, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Signs and Symptoms, Digestive
Signs and Symptoms
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants