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Ondansetron

Phase 1

Nausea | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Ondansetron · 2 trials · 2 indications

Phase 1 2
NCT00946387To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting ConditionsNausea
COMPLETED26 Analytics
NCT00947128To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting ConditionsNausea
COMPLETED26 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions
NauseaUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
NauseaUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
9 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOndansetron HCl 24 mg Tablets (Sandoz, Inc.)
2ACTIVE_COMPARATORZofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Interventions

NameTypeDescription
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)DRUG -
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)DRUG -
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Eligibility Criteria

Age Range22 Years to 58 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Frequently asked questions about Ondansetron

What is Ondansetron used for?

Ondansetron is a small molecule being developed for nausea and vomiting. It is currently in Phase 1 clinical development as an investigational drug. The developer is Novartis AG, which trades under the ticker NVS.

Who makes Ondansetron?

Ondansetron is being developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is currently in Phase 1 clinical trials for the treatment of nausea and vomiting.

What phase is Ondansetron in?

Ondansetron is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both focusing on the bioavailability of the drug under fasting and non-fasting conditions.

What clinical trials is Ondansetron in?

Ondansetron has two completed Phase 1 clinical trials. The first, NCT00946387, studied the relative bioavailability of Ondansetron HCl 24 mg tablets under fasting conditions with 26 participants. The second, NCT00947128, studied the same under non-fasting conditions with 26 participants. Both trials involved healthy volunteers.

How does Ondansetron work?

Ondansetron is a small molecule that works by blocking serotonin receptors in the body, which helps prevent nausea and vomiting. It is being developed for gastrointestinal conditions, specifically to treat nausea and vomiting.