Healthy ParticipantsPhase 1NCT01220167

Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

A Phase 1 study testing Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water and Zofran ODT (ondansetron 8 mg) without water in people with Healthy Participants, run by Aquestive Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water and Zofran ODT (ondansetron 8 mg) without water
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
Study dates: Aug 2008to Aug 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

The criteria for inclusion in the study were:
Study volunteer should provide written informed consent.
Study volunteer must be a healthy adult within 18-45 years of age (inclusive).
Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
Study volunteer should have a normal ECG, chest X-ray and vital signs.
If study volunteer is a female and is of child bearing potential she must be practicing an acceptable method of birth control for the duration of the study.

Who cannot join

The criteria for exclusion from the study were:
Study volunteer incapable of understanding the informed consent.
Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
Study volunteer who smokes regularly more than ten cigarettes daily.
Study volunteer who has taken over the counter or prescribed medications.
Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.

About this study

Official title: Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants

Read the detailed description

This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered without (Test Treatment A) and with water (Test Treatment B) with that of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered without water (Reference Treatment C) in healthy adult participants. The 3 treatment sequences were: ABC, BCA, and CAB, in which, all treatments were administered after an overnight fasting of at least 10 hours in each period.

Participants reported to the study site between 07:30 am to 04:30 pm on 22 Aug 2008, 25 Aug 2008, and 28 Aug 2008 for Period 1, Period 2, \& Period 3, respectively. Participants were served dinner between 8:00 pm to 8:30 pm, to ensure a minimum of 10 hours of fasting prior to administration of a single dose of either the test or reference product. Participants were dosed as per the randomization schedule with a 3-day wash out period between each administration.

A total of 18 blood samples (4 mL each) were collected from each subject in each period for pharmacokinetic analyses. Safety assessments including monitoring of adverse events, periodic physical examination, and vital signs monitoring. Urine Drug Screening was done at the time of check-in of all the study periods to identify participants with any substance abuse. Urine pregnancy screen (for female subjects only) was scheduled at the time of screening and at admission for Period 1, Period 2, Period 3. A clinical assessment, which included general and systemic examination, was done at the pre-study screening and post study physical examination. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study).

Conditions: Healthy Participants
Being tested: Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water, Zofran ODT (ondansetron 8 mg) without water
Keywords: bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ondansetron 8 mg ODFS without waterDrug
Also called Test Treatment (A)
Single dose of Ondansetron 8 mg (ODFS) administered without water
Ondansetron 8 mg ODFS with waterDrug
Also called Test Treatment (B)
Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water
Zofran ODT (ondansetron 8 mg) without waterDrug
Also called Reference Treatment (C)
Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water

Study groups in NCT01220167
Study group	Role	What they receive
Sequence ABC	Experimental	Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. Receives: Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water
Sequence BCA	Experimental	Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. Receives: Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water
Sequence CAB	Experimental	Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. Receives: Drug: Ondansetron 8 mg ODFS without water; Drug: Ondansetron 8 mg ODFS with water; Drug: Zofran ODT (ondansetron 8 mg) without water

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum Plasma Concentration (Time to reach maximum concentration)
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
AUCt
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
AUCinf
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Aug 2008

First posted13 Oct 2010 (estimated)
Study startAug 2008
Primary completionAug 2008
Study completionAug 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 Healthy ParticipantsStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Open label, balanced, randomized three period, three treatment, three sequence, three-way crossover bioavailability study .
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01220167
Sponsor's protocol ID: OND/CR/051/08/09
Status last verified: Aug 2020
First submitted: 12 Oct 2010
Last updated: 18 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants
ClinicalTrials.gov ID: NCT01220167
Acronym / sponsor ID: OND/CR/051/08/09
Conditions: Healthy Participants
Keywords: bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Aquestive TherapeuticsIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 13 Oct 2010 (estimated)
Results: Posted 18 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: Open label, balanced, randomized three period, three treatment, three sequence, three-way crossover bioavailability study .

Arm	Type	Receives
Sequence ABC	Experimental	Drug: Ondansetron 8 mg ODFS without water, Drug: Ondansetron 8 mg ODFS with water, Drug: Zofran ODT (ondansetron 8 mg) without waterSix subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.
Sequence BCA	Experimental	Drug: Ondansetron 8 mg ODFS without water, Drug: Ondansetron 8 mg ODFS with water, Drug: Zofran ODT (ondansetron 8 mg) without waterSix subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.
Sequence CAB	Experimental	Drug: Ondansetron 8 mg ODFS without water, Drug: Ondansetron 8 mg ODFS with water, Drug: Zofran ODT (ondansetron 8 mg) without waterSix subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Study volunteer should provide written informed consent.
Study volunteer must be a healthy adult within 18-45 years of age (inclusive).
Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.

Key exclusion criteria (8 listed)

Study volunteer incapable of understanding the informed consent.
Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
Study volunteer who smokes regularly more than ten cigarettes daily.

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 8 mg ODFS without waterAlso: Test Treatment (A)Single dose of Ondansetron 8 mg (ODFS) administered without water	Drug	Sequence ABC, Sequence BCA, Sequence CAB
Ondansetron 8 mg ODFS with waterAlso: Test Treatment (B)Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water	Drug	Sequence ABC, Sequence BCA, Sequence CAB
Zofran ODT (ondansetron 8 mg) without waterAlso: Reference Treatment (C)Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water	Drug	Sequence ABC, Sequence BCA, Sequence CAB

Primary outcome

Cmax
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Maximum Plasma Concentration (Time to reach maximum concentration)
AUCt
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")
AUCinf
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity

Results and safety

Results posted to the registry on 18 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABC	6	6
Sequence BCA	6	6
Sequence CAB	6	6

Primary outcome: Cmax

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Ondansetron ODFS With or Without Water and Zofran ODT n = 18
ODFS without water	40.866 (13.3089)
ODFS with water	42.843 (15.9103)
Zofran ODT	39.382 (12.3572)

Population analysed: 18 subjects were enrolled. One subject did not complete.

Primary outcome: AUCt

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Ondansetron ODFS With and Without Water and Zofran ODT n = 17
ODFS without water	290.687 (106.5203)
ODFS with water	291.069 (99.5911)
Zofran ODT	285.457 (105.3048)

Population analysed: 18 healthy subjects were enrolled. Only 17 subjects completed the study. 0 to 96 hours post-dose

Primary outcome: AUCinf

Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Ondansetron ODFS With and Without Water and Zofran ODT n = 17
ODFS without water	311.349 (119.7910)
ODFS with water	310.394 (112.7499)
Zofran ODT	306.497 (121.8256)

Population analysed: 18 subject were enrolled. Only 17 completed the study.

Adverse events

Time frame: Adverse event data were collected from the time of the first dose until 30 days following the last dose (overall approximately 1.5 months for each subject). No adverse events were reported during the study and follow-up period. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study). Thus, abnormal laboratory analytes reported as adverse events could not be attributed to any of the 3 study treatments.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ODFS 8 mg With and Without Water and Zofran ODT Without Water	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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, MD principal investigator

Vimta Labs Ltd.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 8 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 18 Aug 2020. 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?

Yes. Results are posted in the registry (first posted 18 Aug 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, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose). 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?

On the ClinicalTrials.gov record for NCT01220167.

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 18 Aug 2020.