Nausea and Vomiting, PostoperativePhase 1/201905/08-09NCT01217190
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
A Phase 1/2 study testing Ondansetron (ODFS) and Zofran (ODT) in people with Nausea and Vomiting, Postoperative and Nausea With Vomiting Chemotherapy-Induced, run by MonoSol Rx at 1 site in India.
Trial summary
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced
- What is being tested?
- Ondansetron (ODFS) and Zofran (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
- 16 Sep 2008to 6 Oct 2008
- Phase
- Phase 1/2
- 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
- Volunteer should have written informed consent.
- Volunteer healthy adult within 18-45 years of age (inclusive).
- Body mass index of 18.5 kg/m^2 and 25 kg/m^2, body weight not less than 50 kg.
- Volunteer must be of normal health.
- Volunteer should have a 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.
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- Criteria: Exclusion Criteria:
- Volunteer doesn't understand the informed consent.
- Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures
- Volunteer who smokes regularly, alcohol or drug abuse
- Volunteer who has taken over the counter or prescribed medications
- Volunteer with clinically significant abnormal values of laboratory parameters.
- Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Randomized, Single Oral Dose, Two-Way Crossover Bioequivalence Study Comparing Ondansetron Orally Dissolving Film Strip 8 mg With Zofran Orally Disintegrating Tablets (ODT) (Containing Ondansetron 8 mg) in Healthy Adults
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.
Read the detailed description
This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.
Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
- Being tested
- Ondansetron (ODFS), Zofran (ODT)
- Keywords
- Bioequivalence, safety, and tolerability
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron (ODFS)Drug
Also called Ondansetron Orally Dissolving Film Strip
Test Article
Zofran (ODT)Drug
Also called Zofran Orally Disintegrating Tablet
Comparator
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron ODFS then Zofran ODT | Experimental | Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods Receives: Drug: Ondansetron (ODFS); Drug: Zofran (ODT) |
| Zofran ODT then Ondansetron ODFS | Experimental | Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods Receives: Drug: Ondansetron (ODFS); Drug: Zofran (ODT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Measured: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
AUCt
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
Measured: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
AUCinf
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Measured: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
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 start16 Sep 2008
- Primary completion26 Sep 2008
- Study completion6 Oct 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 Nausea and Vomiting, PostoperativeStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two period study, two treatment, randomized sequence
- 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, MD, Principal investigator, Vimta Labs Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217190
- Sponsor's protocol ID
- OND/CR/020/08-09
- Acronym
- 01905/08-09
- Status last verified
- Jul 2020
- First submitted
- 6 Oct 2010
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Randomized, Single Oral Dose, Two-Way Crossover Bioequivalence Study Comparing Ondansetron Orally Dissolving Film Strip 8 mg With Zofran Orally Disintegrating Tablets (ODT) (Containing Ondansetron 8 mg) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01217190
- Acronym / sponsor ID
- 01905/08-09 / OND/CR/020/08-09
- Keywords
- Bioequivalence, safety, and tolerability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- MonoSol RxIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2008 (actual)
- Primary completion
- 26 Sep 2008 (actual)
- Study completion
- 6 Oct 2008 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.
Detailed description
This was an open label, balanced, randomized, two-treatment, two-period, randomized sequence crossover study conducted in healthy adult male and female volunteers. Subjects checked into the study center on Day -1 of each study period at least 12 hours prior to dosing on Day 1. Subjects were served dinner between 8:00 pm to 8:30 pm to ensure minimum 10 hours fast prior to dosing in both periods. Subjects received the 2 treatments in a randomized order with a 7-day washout between the 2 periods.
Treatment A: single dose of ondansetron ODFS 8 mg was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
Treatment B: single dose of Zofran ODT (containing ondansetron 8 mg) was orally administered, allowed to dissolve, swallowed with saliva, followed with 240 mL room temperature drinking water
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two period study, two treatment, randomized sequence
| Arm | Type | Receives |
|---|---|---|
| Ondansetron ODFS then Zofran ODT | Experimental | Drug: Ondansetron (ODFS), Drug: Zofran (ODT)Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods |
| Zofran ODT then Ondansetron ODFS | Experimental | Drug: Ondansetron (ODFS), Drug: Zofran (ODT)Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Volunteer should have written informed consent.
- Volunteer healthy adult within 18-45 years of age (inclusive).
- Body mass index of 18.5 kg/m^2 and 25 kg/m^2, body weight not less than 50 kg.
- Volunteer must be of normal health.
- Volunteer should have a normal ECG, chest X-ray and vital signs.
Key exclusion criteria (0 listed)
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: Ondansetron Orally Dissolving Film StripTest Article | Drug | Ondansetron ODFS then Zofran ODT, Zofran ODT then Ondansetron ODFS |
| Zofran (ODT)Also: Zofran Orally Disintegrating TabletComparator | Drug | Ondansetron ODFS then Zofran ODT, Zofran ODT then Ondansetron ODFS |
Primary outcome
Cmax
Time frame: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
AUCt
Time frame: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
AUCinf
Time frame: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD principal investigator
Vimta Labs Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ondansetron (ODFS) and Zofran (ODT) in people with Nausea and Vomiting, Postoperative and Nausea With Vomiting Chemotherapy-Induced, 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 15 inclusion and 0 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 29 Jul 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Jul 2020). 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?
Cmax (time frame: 0,0.33,0.67,1,1.33,1.67,2,2.33,2.67,3,4,6,8,10,12,15,18,24 hours). The study lists 3 primary outcomes in all. 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 29 Jul 2020.