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A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

Phase 1
Completed
Conditions
Chemotherapy-Induced Nausea and Vomiting
Registration Number
NCT00971633
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria
  • If female, subject is not pregnant or breast-feeding
  • Subject is a nonsmoker
  • Subject is in good general health
Exclusion Criteria
  • Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
  • Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
  • Subject is a habitual and heavy consumer of caffeine

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Maximum Plasma Concentration (Cmax) of Ondansetron24 hours post dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
Secondary Outcome Measures
NameTimeMethod

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