Status:
COMPLETED
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- If female, subject is not pregnant or breast-feeding
- Subject is a nonsmoker
- Subject is in good general health
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00971633
Start Date
November 1 2003
End Date
January 1 2004
Last Update
September 14 2016
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