Healthy VolunteersPhase 1NCT06284902

Bioavailability Study of Fexofenadine HCl New Formulation Tablet

A Phase 1 study testing Fexofenadine HCl Coated tablet and Fexofenadine HCl New Formulation Tablet in people with Healthy Volunteers, run by Opella Healthcare Group SAS, a Sanofi Company at 1 site in Canada.

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

The purpose of the study is to assess the relative bioavailability of a new galenic form of fexofenadine HCl new formulation tablet (test drug) taken with or without water compared to fexofenadine HCl film-coated tablets (reference form) taken with water under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Fexofenadine HCl Coated tablet and Fexofenadine HCl New Formulation Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteCanada
Study dates: 23 Feb 2024to 23 May 2024
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body-mass-index (BMI) >18 and <29.9 kilogram per meter square (kg/m^2) and body weight ≥50.0 kg to ≤100.0 kg for males and ≥40.0 kg to ≤90.0 kg for females.
Healthy as defined by:
the absence of clinically significant illness and surgery within 4 weeks prior to inclusion on Day 1.
the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
Standard 12-lead electrocardiogram (ECG) parameters after 5 minutes resting in supine position in the following ranges:120 milliseconds (ms)<PR<220 ms, QRS<120 ms, QTcF≤450 ms if male, ≤470 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
Female participants of non-childbearing potential must be:

Show all 19Show fewer

post-menopausal (spontaneous amenorrhea for at least 12 months prior to inclusion on Day 1) with confirmation by documented follicle-stimulating hormone (FSH) levels 30 milli-international units per milliliter (mIU/mL); or
surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy or tubal ligation) at least 3 months prior to inclusion on Day 1.
Female participants of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to inclusion on Day 1) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last dose:
simultaneous use of hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to inclusion on Day 1 (must agree to use the same contraceptive throughout the study) and condom for the male partner;
simultaneous use of non-hormonal intrauterine device placed at least 4 weeks prior to inclusion on Day 1 and condom for the male partner;
simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to inclusion on Day 1.
Male participants who are not vasectomized for at least 3 months prior to inclusion on Day 1 and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first dose and for 90 days after the last dose:
simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;
simultaneous use of condom and a diaphragm or cervical cap with spermicide for the female partner.
Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose.
Male participants must be willing not to donate sperm for 90 days after the last dose.
Willing to take off dentures or mouth piercing at the time of dosing.
Able to understand the study procedures and provide signed informed consent to participate in the study.

Who cannot join

Any clinically significant abnormal finding at physical examination at screening.
Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
Frequent history of headaches and/or migraine more than twice a month, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
Positive pregnancy test or lactating female participant.
Positive urine drug screen, urine cotinine test, or alcohol breath test.
Known allergic reactions to fexofenadine HCl or other related drugs, or to any excipient in the formulation.

Show all 28Show fewer

Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 95 or over 140 mmHg, diastolic blood pressure lower than 45 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease of ≥20 mmHg in systolic blood pressure, decrease of ≥10 mmHg in diastolic blood pressure, and increase of ≥30 bpm in heart rate within 3 minutes when changing from supine to standing position.
History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the pharmacokinetic (PK) profile of the study drug or participant safety (e.g., topical drug products without significant systemic absorption):
any biologics (antibody or its derivatives) given within 4 months prior to inclusion on Day 1;
depot injection or implant within 3 months prior to inclusion on Day 1;
any drug known to induce or inhibit cytochrome P450 (CYP)3A4 metabolism, including St. John's wort, within 30 days prior to inclusion on Day 1;
prescription medications within 14 days prior to inclusion on Day 1;
any vaccine, including COVID-19 vaccine, within 28 days prior to inclusion on Day 1;
over-the-counter (OTC) medications and natural health products (including herbal remedies such as homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to inclusion on Day 1, with the exception of the occasional use of acetaminophen (up to 2 g daily);
any drug known to be P-glycoproteins (Pg-p) inhibitors or inducers, Organic anion transporting polypeptides (OATP) inhibitors or inducers or any medication containing ketoconazole (e.g., Nizoral), itraconazole, verapamil, erythromycin, rifampin, and carbamazepine within 14 days prior to inclusion on Day 1 and during the study period.
any antacids containing aluminum and magnesium within 14 days prior to inclusion on Day 1 and during the study period.
any antihistaminic drug within 14 days prior to inclusion on Day 1.
any tricyclic antidepressants within 14 days prior to inclusion on Day 1.
Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to inclusion on Day 1, administration of a biological product in the context of a clinical research study within 90 days prior to inclusion on Day 1, or concomitant participation in an investigational study involving no drug or device administration.
Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first inclusion on Day 1.
Presence of orthodontic braces or orthodontic retention wires or dentures, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
Presents difficulty with venipuncture and/or poor venous access.
Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Syneos Health Clinic inc.
Québec, Quebec, G1P 0A2

Other trials in Canada

About this study

Official title: Open-Label, Single-Dose, Randomized, 6-Treatment, 6-Sequence, 6-Period Crossover Relative Bioavailability Study Comparing Fexofenadine HCl New Formulation Tablets (Test Drug) With or Without Water to Fexofenadine HCl Coated Tablets (Reference Drug) With Water in Healthy Male and Female Subjects Under Fasting Conditions

Conditions: Healthy Volunteers
Being tested: Fexofenadine HCl Coated tablet, Fexofenadine HCl New Formulation Tablet

What participants receive

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

Fexofenadine HCl Coated tabletDrug
Film-coated tablet.
Fexofenadine HCl New Formulation TabletDrug
New formulation tablet.

Study groups in NCT06284902
Study group	Role	What they receive
Treatment Sequence Group 1	Experimental	Not described Receives: Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 2	Experimental	Not described Receives: Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 3	Experimental	Not described Receives: Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 4	Experimental	Not described Receives: Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 5	Experimental	Not described Receives: Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 6	Experimental	Not described Receives: Drug: Fexofenadine HCl Coated tablet; Drug: Fexofenadine HCl New Formulation Tablet

What is being measured

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

Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hours (hrs) post-dose
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Maximal Observed Concentration (Cmax) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

Secondary outcomes (5)

Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Terminal Elimination Rate Constant (Kel) of Fexofenadine
Measured: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A TEAE is defined as AEs that occurred or worsened at any time during the on-treatment period are defined as treatment-emergent adverse events.
Measured: From screening up to 7-10 days post last dose (approximately 13 weeks)

Timeline

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

23 Feb 202423 May 2024

First posted29 Feb 2024
Study start23 Feb 2024
Primary completion8 May 2024
Study completion23 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06284902
Sponsor's protocol ID: BDR17987
Status last verified: Sep 2025
First submitted: 22 Feb 2024
Last updated: 12 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Single-Dose, Randomized, 6-Treatment, 6-Sequence, 6-Period Crossover Relative Bioavailability Study Comparing Fexofenadine HCl New Formulation Tablets (Test Drug) With or Without Water to Fexofenadine HCl Coated Tablets (Reference Drug) With Water in Healthy Male and Female Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT06284902
Acronym / sponsor ID: BDR17987
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Opella Healthcare Group SAS, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 23 Feb 2024 (actual)
Primary completion: 8 May 2024 (actual)
Study completion: 23 May 2024 (actual)
First posted: 29 Feb 2024 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment Sequence Group 1	Experimental	Drug: Fexofenadine HCl Coated tablet, Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 2	Experimental	Drug: Fexofenadine HCl Coated tablet, Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 3	Experimental	Drug: Fexofenadine HCl Coated tablet, Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 4	Experimental	Drug: Fexofenadine HCl Coated tablet, Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 5	Experimental	Drug: Fexofenadine HCl Coated tablet, Drug: Fexofenadine HCl New Formulation Tablet
Treatment Sequence Group 6	Experimental	Drug: Fexofenadine HCl Coated tablet, Drug: Fexofenadine HCl New Formulation Tablet

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (19 listed)

Male or female non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body-mass-index (BMI) >18 and <29.9 kilogram per meter square (kg/m^2) and body weight ≥50.0 kg to ≤100.0 kg for males and ≥40.0 kg to ≤90.0 kg for females.
Healthy as defined by:
Standard 12-lead electrocardiogram (ECG) parameters after 5 minutes resting in supine position in the following ranges:120 milliseconds (ms)<PR<220 ms, QRS<120 ms, QTcF≤450 ms if male, ≤470 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
Female participants of non-childbearing potential must be:
Female participants of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to inclusion on Day 1) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last dose:

Key exclusion criteria (28 listed)

Any clinically significant abnormal finding at physical examination at screening.
Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
Frequent history of headaches and/or migraine more than twice a month, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
Positive pregnancy test or lactating female participant.
Positive urine drug screen, urine cotinine test, or alcohol breath test.

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
Fexofenadine HCl Coated tabletFilm-coated tablet.	Drug	Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3, Treatment Sequence Group 4, Treatment Sequence Group 5, Treatment Sequence Group 6
Fexofenadine HCl New Formulation TabletNew formulation tablet.	Drug	Treatment Sequence Group 1, Treatment Sequence Group 2, Treatment Sequence Group 3, Treatment Sequence Group 4, Treatment Sequence Group 5, Treatment Sequence Group 6

Primary outcome

Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hours (hrs) post-dose
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (AUC0-inf) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Maximal Observed Concentration (Cmax) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose

5 secondary outcomes

Time When the Maximal Concentration is Observed (Tmax) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Time of Observation Prior to the First Observation with a Measurable (non-zero) Concentration (Tlag) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Terminal Half-life Associated with the Terminal Slope (T1/2z) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Terminal Elimination Rate Constant (Kel) of Fexofenadine
Time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hrs post-dose
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From screening up to 7-10 days post last dose (approximately 13 weeks)

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 12 Sep 2025.
BDR17987 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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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.

Clinical Sciences & Operations study director

Sanofi

1 site in 1 country: see every site and its status.

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 19 inclusion and 28 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 12 Sep 2025. 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?

Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-t) of Fexofenadine (time frame: Pre-dose and 0.17, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0, and 48.0 hours (hrs) 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 NCT06284902.

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 12 Sep 2025.