HealthyPhase 1NCT01217801
Two Way Bioequivalence Study Under Fed Conditions
A Phase 1 study testing Ondansetron (ODFS) and Ondansetron (ODT) in people with Healthy, run by MonoSol Rx at 1 site in India.
Trial summary
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ondansetron (ODFS) and Ondansetron (ODT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- provide written informed consent.
- healthy adult within 18-45 years of age (inclusive).
- Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
- normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
- Normal ECG, chest X-ray and vital signs.
- If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.
Who cannot join
- The study participants were excluded based on the following criteria:
- incapable of understanding the informed consent.
- history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function
- volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma .
- smokes regularly more than ten cigarettes daily
Show all 11Show fewer
- taken over the counter or prescribed medications
- history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation.
- history of alcohol or substance abuse within the last 5 years.
- clinically significant abnormal values of laboratory parameters.
- positive urine screen for drugs of abuse at the time of admission check-in for each period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions.
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.
The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.
Read the detailed description
An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets [ODT® (Containing Ondansetron 8 mg)] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.
- Conditions
- Healthy
- Being tested
- Ondansetron (ODFS), Ondansetron (ODT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron (ODFS)Drug
Also called Zuplenz
Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
Ondansetron (ODT)Drug
Also called Zofran
Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron (ODFS) | Experimental | single dose of Ondansetron Orally Dissolving Filmstrip 8 mg Receives: Drug: Ondansetron (ODFS) |
| Zofran (ODT) | Active comparator | Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg Receives: Drug: Ondansetron (ODT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Plasma Concentration
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- MonoSol Rx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudershan Vishwanath, Study director, Vimta VHS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217801
- Sponsor's protocol ID
- OND/CR/021/08-09/01906
- Status last verified
- Mar 2017
- First submitted
- 7 Oct 2010
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01217801
- Acronym / sponsor ID
- OND/CR/021/08-09/01906
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- MonoSol RxIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.
The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.
Detailed description
An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets [ODT® (Containing Ondansetron 8 mg)] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron (ODFS) | Experimental | Drug: Ondansetron (ODFS)single dose of Ondansetron Orally Dissolving Filmstrip 8 mg |
| Zofran (ODT) | Active comparator | Drug: Ondansetron (ODT)Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- provide written informed consent.
- healthy adult within 18-45 years of age (inclusive).
- Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
- normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
Key exclusion criteria (11 listed)
- The study participants were excluded based on the following criteria:
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 (ODFS)Also: ZuplenzOndansetron Orally Dissolving Filmstrip Ondansetron (ODFS) | Drug | Ondansetron (ODFS) |
| Ondansetron (ODT)Also: ZofranOndansetron Orally Disintegrating Tablet Ondanestron (ODT) | Drug | Zofran (ODT) |
Primary outcome
Area Under Plasma Concentration
Time frame: Day 1 and Day 7
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sudershan Vishwanath study director
Vimta VHS Research Centre
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 Ondansetron (ODFS) and Ondansetron (ODT) in people with Healthy, run by MonoSol Rx at 1 site in India.
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 11 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 2 May 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 India. 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?
Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under Plasma Concentration (time frame: Day 1 and Day 7). 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 2 May 2017.