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ondansetron clinical trial 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 clinical trial 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 Vomiting
NCT0097259545
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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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