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Ondansetron for infusion

Phase 1

Chemotherapy-Induced Nausea and Vomiting (CINV) | Small molecule | Other |Nasus Pharma Ltd.|Trials Updated: Oct 9, 2026

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Ondansetron for infusion clinical trials

Ondansetron for infusion · 1 trial · 3 indications

Phase 1 1
NCT07868861A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy AdultsChemotherapy-Induced Nausea and Vomiting (CINV)
RECRUITING12 Analytics
PHASE1RECRUITING
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV)
NCT0786886112
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Study Endpoints

Primary Endpoints

Ondansetron plasma concentrations over time
Time zero (dosing) to 24 hours post dose

Measurement in 15 time points

Cmax
Time zero (doing) to 24 hours post dose

Maximum Ondansetron level in plasma

Tmax
Time zero (doing) to 24 hours post dose

Time to maximum Ondansetron level in plasma

Area Under the Curve (AUC)
Time zero to 24 hours post dose (several trancations over time)

Total exposure to Ondansetron

Kel
From time zero (dosing) to 24 hours post dose

The apparent first-order elimination rate constant

Thalf
From time zero (dosing) to 24 hours post dose

The apparent elimination half-life

AUCt/AUCinf
From time zero (dosing) to 24 hours post dose

The ratio of AUCt to AUCinf

Secondary Endpoints

Number of Participants With Adverse Events (AEs)
Dosing to follow-up visit (1 week after last dose)
Number of Participants With Serious Adverse Events (SAEs)
Dosing to follow-up visit (1 week after last dose)
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Dosing to follow-up visit (1 week after last dose)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
NS003 Ondansetron HCl for nasal application, 5 mgEXPERIMENTAL -
NS003 Ondansetron HCl for nasal application, 10 mgEXPERIMENTAL -
Marketed Ondansetron Solution, for IV infusion (total dose 8 mg)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
NS003 Ondansetron HCl microspheres powder for nasal applicationDRUGusing nasal device (test)
Ondansetron Solution for IV infusion 8mgDRUGAvailable marketed formulation (reference)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 me...

Countries:Israel
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Recent Changes (Last 90 Days)

LOWOct 9, 2026NCT07868861NEW_TRIAL: changed
LOWOct 9, 2026NCT07868861NEW_TRIAL: changed

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