NauseaPhase 1NCT01036854
Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)
A Phase 1 study testing EUR-1025 in people with Nausea, run by Forest Laboratories at 1 site in Canada.
Trial summary
The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken 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?
- EUR-1025
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Apr 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
- Body mass index targeted to be at least 18.5 and less than 30 kg/m2.
- Acceptable lab tests
- Normal 12 lead ECG
- Negative human chorionic gonadotropin (hCG) for females.
Who cannot join
- No known hypersensitivity to Ondansetron or any related products
- No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption
- No presence of significant heart disease or disorder discovered on screening ECG
- Not pregnant
- No alcohol or drug abuse history
- No use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP)
- No previous 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations
The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.
Read the detailed description
The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.
- Conditions
- Nausea
- Being tested
- EUR-1025
- Keywords
- Ondansetron, EUR-1025
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUR-1025Drug
Also called Ondansetron
orally, 24 mg, daily for 6 days
EUR-1025Drug
Also called Ondansetron
orally, 8 mg, twice daily over 6 consecutive days
EUR-1025Drug
Also called Ondansetron
orally, 8 mg, three times a day over 6 consecutive days
EUR-1025Drug
Also called Ondansetron
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Regime 1 | Experimental | Regime 1 will be orally administered once daily in the morning over 6 consecutive days. Receives: Drug: EUR-1025 |
| Regime 2 | Active comparator | Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days Receives: Drug: EUR-1025 |
| Regime 3 | Active comparator | Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days. Receives: Drug: EUR-1025 |
| Regime 4 | Experimental | Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 \& 5- two placebo capsules on each day; Day 6- a single does will be given. Receives: Drug: EUR-1025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionApr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 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
- NCT01036854
- Sponsor's protocol ID
- ODO-P8-690
- Status last verified
- Feb 2017
- First submitted
- 17 Dec 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
- Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations
- ClinicalTrials.gov ID
- NCT01036854
- Acronym / sponsor ID
- ODO-P8-690
- Conditions
- Nausea
- Keywords
- Ondansetron, EUR-1025
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Dec 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.
The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.
Detailed description
The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regime 1 | Experimental | Drug: EUR-1025Regime 1 will be orally administered once daily in the morning over 6 consecutive days. |
| Regime 2 | Active comparator | Drug: EUR-1025Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days |
| Regime 3 | Active comparator | Drug: EUR-1025Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days. |
| Regime 4 | Experimental | Drug: EUR-1025Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 \& 5- two placebo capsules on each day; Day 6- a single does will be given. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female volunteers
- Non- or ex-smokers
- At least 21 years of age but not older than 55 years
- Body mass index targeted to be at least 18.5 and less than 30 kg/m2.
- Acceptable lab tests
Key exclusion criteria (7 listed)
- No known hypersensitivity to Ondansetron or any related products
- No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption
- No presence of significant heart disease or disorder discovered on screening ECG
- Not pregnant
- No alcohol or drug abuse history
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 |
|---|---|---|
| EUR-1025Also: Ondansetronorally, 24 mg, daily for 6 days | Drug | Regime 1 |
| EUR-1025Also: Ondansetronorally, 8 mg, twice daily over 6 consecutive days | Drug | Regime 2 |
| EUR-1025Also: Ondansetronorally, 8 mg, three times a day over 6 consecutive days | Drug | Regime 3 |
| EUR-1025Also: Ondansetronorally, 8 mg, 16 mg, 24 mg, daily, for 6 days | Drug | Regime 4 |
Primary outcome
Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.
Time frame: 6 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EUR-1025 in people with Nausea, run by Forest Laboratories at 1 site in Canada.
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 7 inclusion and 7 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.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay. (time frame: 6 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.