NauseaPhase 1NCT00947128
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
A Phase 1 study testing Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) and Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) in people with Nausea and Vomiting, run by Sandoz.
Trial summary
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions. Read more about this study
- Who is it for?
- Ages 20 to 58 yearsHealthy volunteers can take part
- What is being tested?
- Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) and Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Oct 2004
- 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 20 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Who cannot join
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
About this study
Official title: A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.
- Being tested
- Ondansetron HCl 24 mg Tablets (Sandoz, Inc.), Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
- Keywords
- Antiemetic
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)Drug
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) Receives: Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) |
| 2 | Active comparator | Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) Receives: Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on AUC and Cmax
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startSep 2004
- Primary completionOct 2004
- Study completionOct 2004
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Soran Hong, M.D., Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947128
- Sponsor's protocol ID
- B043713
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
- ClinicalTrials.gov ID
- NCT00947128
- Acronym / sponsor ID
- B043713
- Keywords
- Antiemetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 27 Jul 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.
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) |
| 2 | Active comparator | Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) |
Who may qualify
- Ages
- 20 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Key exclusion criteria (2 listed)
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
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 |
|---|---|---|
| Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) | Drug | 1 |
| Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) | Drug | 2 |
Primary outcome
Bioequivalence based on AUC and Cmax
Time frame: 9 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 28 Mar 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.
Soran Hong, M.D. principal investigator
Novum Pharmaceutical Research Services
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) and Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) in people with Nausea and Vomiting, run by Sandoz.
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 1 inclusion and 2 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 28 Mar 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?
Bioequivalence based on AUC and Cmax (time frame: 9 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 28 Mar 2017.