NauseaPhase 1ODO-P8-689NCT00981487
Bioavailability Study of Anti Nausea Medication With and Without Food (EUR-1025)
A Phase 1 study testing Ondansetron in people with Nausea, run by Forest Laboratories.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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,
Show all 19Show fewer
- 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.
About this study
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
This study is to assess the effect of food on a single dose of Ondansetron when taken with a meal on an empty stomach.
Read the detailed 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.
- Conditions
- Nausea
- Being tested
- Ondansetron
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called EUR-1025
24 mg one time
OndansetronDrug
Also called EUR-1025
24 mg, on time in the am
| Study group | Role | What they receive |
|---|---|---|
| Fed | Experimental | A single oral dose of EUR-1025 (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. Receives: Drug: Ondansetron |
| Fasting | Experimental | A single oral dose of EUR-1025 (1 x 24 mg) will be administered with approximately 240 ml of water in the morning after a 10-hour overnight fast. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of food on the pharmacokinetics of a single 24 mg dose of ondansetron administered under fed and fasting conditions
Measured: 1 dose on two separate days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, M.D., Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981487
- Sponsor's protocol ID
- EUR-1025
- Acronym
- ODO-P8-689
- Status last verified
- Feb 2017
- First submitted
- 21 Sep 2009
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00981487
- Acronym / sponsor ID
- ODO-P8-689 / EUR-1025
- Conditions
- Nausea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the effect of food on a single dose of Ondansetron when taken with a meal 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 Ondansetron administered as a novel modified-release capsule formulation under fed and fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed | Experimental | Drug: OndansetronA single oral dose of EUR-1025 (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. |
| Fasting | Experimental | Drug: OndansetronA single oral dose of EUR-1025 (1 x 24 mg) will be administered with approximately 240 ml of water in the morning after a 10-hour overnight fast. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: EUR-102524 mg one time | Drug | Fed |
| OndansetronAlso: EUR-102524 mg, on time in the am | Drug | Fasting |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Related trials for Nausea
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sicard, M.D. principal investigator
Algorithme Pharma Inc
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ondansetron in people with Nausea, run by Forest Laboratories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.