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ondansetron marketed formulation

Phase 1

Chemotherapy-Induced Nausea and Vomiting | Small molecule | Other |Merck & Company, Inc.|Last Updated: Aug 19, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

ondansetron marketed formulation · 1 trial · 1 indication

Phase 1 1
NCT00972595Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)Chemotherapy-Induced Nausea and Vomiting
COMPLETED45 Analytics
PHASE1COMPLETED
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Chemotherapy-Induced Nausea and VomitingUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose
Peak Plasma Concentration (Cmax) for Ondansetron
24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALclinical trial formulation
BACTIVE_COMPARATORnon-U.S. marketed formulation

Interventions

NameTypeDescription
ondansetron clinical trial formulationDRUGSingle dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
ondansetron marketed formulationDRUGSingle dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * If female, subject is not pregnant or breast-feeding * Subject has been a nonsmoker for at least 6 months * Subject is in good health Exclusion Criteria: * Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/pept...

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Frequently asked questions about ondansetron marketed formulation

What is ondansetron marketed formulation used for?

Ondansetron marketed formulation is used for chemotherapy-induced nausea and vomiting. It is a small molecule being developed by Merck & Company, Inc. for this indication. The drug is currently in Phase 1 clinical development.

Who makes ondansetron marketed formulation?

Ondansetron marketed formulation is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate this small molecule for chemotherapy-induced nausea and vomiting.

What phase is ondansetron marketed formulation in?

Ondansetron marketed formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for chemotherapy-induced nausea and vomiting.

What clinical trials is ondansetron marketed formulation in?

Ondansetron marketed formulation has one completed Phase 1 clinical trial, NCT00972595, titled "Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)". The trial enrolled 45 healthy adult volunteers and was active-controlled.

Is ondansetron marketed formulation the same as ondansetron?

Ondansetron marketed formulation is a formulation of ondansetron, a medication used for chemotherapy-induced nausea and vomiting. The clinical trial NCT00972595 compared two formulations of ondansetron for bioequivalence in healthy adults.