Status:
COMPLETED
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
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 non-U.S. marketed formulation of ondansetron.
Eligibility Criteria
Inclusion
- 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
- Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease
- Subject is a habitual and heavy consumer of caffeine
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00972595
Start Date
June 1 2004
End Date
September 1 2004
Last Update
August 19 2015
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