See how nasal ondansetron compares to IV in healthy adults
Official title: A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Run by Nasus Pharma · NCT07868861 · Data updated 2026-11-12
This study tests whether a nasal spray form of ondansetron delivers similar blood levels as the IV version in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Nasus Pharma Industry-sponsored |
| Locations | 1 site (Jerusalem) |
| Status | Recruiting |
| Started | September 15, 2026 |
| Main results expected | January 2027 |
| Study ends | February 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07868861 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults 18–65 who are non-smokers, have BMI 18–30, and have suitable venous access with no conflicting medical conditions.
✕Probably not a fit
Patients with certain medical conditions or those outside the eligibility criteria may not benefit or could be excluded due to safety considerations.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial compares the bioavailability of NS003 ondansetron delivered as a nasal microsphere powder to the standard IV ondansetron solution in healthy adults aged 18–65 who smoke-free and meet other health criteria. Participants will receive both administrations under controlled conditions to measure blood levels and pharmacokinetics. The study includes strict eligibility, monitoring, and confinement periods to ensure accurate comparison. Primary goals are safety and how much drug reaches the bloodstream from each route.
Why it matters
Potential benefit: If successful, the nasal form could offer an alternative route of administration with comparable blood levels to IV, potentially simplifying dosing in clinical settings.
How similar studies have gone: Prior work in comparing nasal and IV ondansetron supports feasibility of noninvasive delivery, though this specific formulation is being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Non-smoking, male and female subjects from 18 to 65 years of age.
2. BMI 18-30 kg/m2.
3. Females may be of childbearing or non-childbearing potential:
* Childbearing potential:
o Physically capable of becoming pregnant, must be willing to use acceptable effective methods of contraception
* Non-childbearing potential:
* Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
* Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause)
4. Able to tolerate venipuncture.
5. Be informed of the nature of the study and give written consent prior to any study procedure.
6. Willing and being able to remain in the clinic for the entire duration of the confinement period.
7. Have good intravenous access on both arms and hands.
8. TNSS Score =0
Exclusion Criteria:
1. Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, hepatic , psychiatric, or cardiovascular disease (including bradyarrhythmias) or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. Known history or presence of hypersensitivity reaction to ondansetron (Zofran), any excipients of ondansetron, or any other drug substances with similar activity.
(commercial names in Israel: ODNATRON injection; ONDANSETRON - FRESENIUS injection; ONDANSETRON KALCEKS injection; ONDANSETRON INOVAMED oral tabs, ONDANSETRON BAXTER injection; Zofran oral tabs).
3. Known history or presence of any food allergy.
4. Presence of nostril or septum piercing which may interfere with nasal administration.
5. Presence of abnormal nasal anatomy (e.g., polyps, unilateral or bilateral abnormalities of the nares, nasal turbinates, or septum including deviated septum).
6. History of nasal surgery.
7. Presence of a medical condition requiring medication (prescription and/or over-the-counter) with systemic absorption other than oral contraceptives or hormone replacement therapy.
8. History of drug or alcohol addiction requiring treatment or positive drug/alcohol test at screening and check-in.
9. Any acute illness (e.g. cold, acute infection) which is considered significant by the Investigator and that has not resolved within 7 days before the first drug administration.
10. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
11. Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
12. Difficulty fasting or consuming standard meals.
13. Inability to communicate well with the Investigators and staff.
14. Non-cooperative or unwilling to sign consent form or unwilling to attend scheduled clinic visits and/or comply with the study protocol.
15. Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
16. Females who:
* Are pregnant (hCG result consistent with pregnancy); or
* Are lactating.
17. Donation or loss of whole blood (including clinical trials):
* ≥50 mL and \<500 mL within 30 days prior to drug administration;
* ≥500 mL within 56 days prior to drug administration.
18. Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
19. On a special diet within 20 days prior to drug administration (e.g., liquid, protein, raw food diet).
20. Have had a tattoo or body piercing within 30 days prior to drug administration.
21. Have clinically significant findings in vital signs measurements at screening.
22. Have clinically significant findings in a 12-lead ECG, specifically abnormal QT/QTc interval
23. Subjects with congenital long QT syndrome
24. Have clinically significant abnormal laboratory values and hemoglobin \<135 g/L for males or \<120 g/L for females at screening.
25. Subjects with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia)
26. Have significant diseases at screening.
27. Have clinically significant findings from a physical examination.
28. Use of the following drugs within 30 days prior to drug administration:
* Apomorphine (contraindication)
* Drugs having effect on cytochrome P450 (CYP450);
* Serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue)
* Medicinal products that lead to QT prolongation (e.g. Amiodarone, Citalopram, Clarithromycin, Diphenhydramine, Erythromycin, Fluconazole - not exhaustive)
29. Use of the following drugs within 7 days prior to drug administration:
* Nasal decongestants including nasal antihistamines;
* Nonsteroidal anti-inflammatory drugs (NSAIDs); or
* Oral or topical antihistamines.
30. Use of any medication within 1 year prior to drug administration with Thalf longer than 1 week
Where it's running
-
Hadassah Medical Center
Jerusalem, Israel Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HR20013 for preventing nausea and vomiting in cancer patients receiving chemotherapy
This real-world study tests whether HR20013 helps prevent nausea and vomiting in adults with cancer who are getting chemotherapy.
-
Postoperative nausea, vomiting and pain after bariatric surgery in Sweden
This study looks at how often people have nausea, vomiting, and pain after bariatric surgery in Sweden and whether anesthesia type or regional blocks affect those outcomes.
-
Foslorapitant with Palonosetron to Help Prevent Nausea and Vomiting from Trastuzumab Rezetecan
A single-arm study tests whether giving foslorapitant plus palonosetron can prevent chemotherapy-induced nausea and vomiting in adults receiving Trastuzumab Rezetecan.
-
Time to first rescue antiemetic after two dual-drug regimens for PONV in gallbladder surgery
This trial tests whether ondansetron plus metoclopramide delays the need for rescue antiemetic more than dexamethasone plus metoclopramide in adults at moderate-to-high risk undergoing laparoscopic cholecystectomy.
-
Comfort Tote to help recovery after scoliosis surgery in teens
This study tests whether a therapeutic Comfort Tote can reduce pain and anxiety after surgery for adolescent idiopathic scoliosis.
-
Menstrual cycle effects on optic nerve sheath diameter during laparoscopic gynecologic surgery
This study will try to see if menstrual cycle phase changes the optic nerve sheath size and affects postoperative nausea, vomiting, and thinking in women having elective laparoscopic gynecologic surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.