Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
NCT ID: NCT00972595
Last Updated: 2015-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2004-06-30
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A
clinical trial formulation
ondansetron clinical trial formulation
Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
B
non-U.S. marketed formulation
ondansetron marketed formulation
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Interventions
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ondansetron clinical trial formulation
Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
ondansetron marketed formulation
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has been a nonsmoker for at least 6 months
* Subject is in good health
Exclusion Criteria
* Subject is a habitual and heavy consumer of caffeine
18 Years
55 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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MK0869-106
Identifier Type: -
Identifier Source: secondary_id
2009_657
Identifier Type: -
Identifier Source: secondary_id
0869-106
Identifier Type: -
Identifier Source: org_study_id
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