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A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults

ConditionsChemotherapy-Induced Nausea and Vomiting (CINV)Radiotherapy-induced Nausea and Vomiting (RINV)Postoperative Nausea and Vomiting
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNasus Pharma

About this trial

A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Non-smoking, male and female subjects from 18 to 65 years of age.

BMI 18-30 kg/m2.

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)

Disqualifiers

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.

Known history or presence of hypersensitivity reaction to ondansetron (Zofran), any excipients of ondansetron, or any other drug substances with similar activity.

Known history or presence of any food allergy.

Presence of nostril or septum piercing which may interfere with nasal administration.

Trial design

Design model

Crossover

Treatments tested in this trial

  • NS003 Ondansetron HCl microspheres powder for nasal application

    Drug

    using nasal device (test)

  • Ondansetron Solution for IV infusion 8mg

    Drug

    Available marketed formulation (reference)

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: NS003 Ondansetron HCl for nasal application, 5 mgExperimental treatment 1 intervention
Group B: NS003 Ondansetron HCl for nasal application, 10 mgExperimental treatment 1 intervention
Group C: Marketed Ondansetron Solution, for IV infusion (total dose 8 mg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ondansetron plasma concentrations over time

Measurement in 15 time points

Time frame
Time zero (dosing) to 24 hours post dose
2

Cmax

Maximum Ondansetron level in plasma

Time frame
Time zero (doing) to 24 hours post dose
3

Tmax

Time to maximum Ondansetron level in plasma

Time frame
Time zero (doing) to 24 hours post dose
4

Area Under the Curve (AUC)

Total exposure to Ondansetron

Time frame
Time zero to 24 hours post dose (several trancations over time)

Secondary outcomes

1

Number of Participants With Adverse Events (AEs)

Time frame
Dosing to follow-up visit (1 week after last dose)
2

Number of Participants With Serious Adverse Events (SAEs)

Time frame
Dosing to follow-up visit (1 week after last dose)
3

Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Time frame
Dosing to follow-up visit (1 week after last dose)
4

Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

Time frame
Screening to follow-up visit (1 week after last dose)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nasus Pharma

Lead sponsor

Source ClinicalTrials.gov
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