Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
3 other identifiers
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2004
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 7, 2009
CompletedResults Posted
Study results publicly available
June 22, 2010
CompletedAugust 19, 2015
August 1, 2015
2 months
September 3, 2009
May 19, 2010
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
A
EXPERIMENTALclinical trial formulation
B
ACTIVE COMPARATORnon-U.S. marketed formulation
Interventions
Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Eligibility Criteria
You may qualify if:
- If female, subject is not pregnant or breast-feeding
- Subject has been a nonsmoker for at least 6 months
- Subject is in good health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 7, 2009
Study Start
June 1, 2004
Primary Completion
August 1, 2004
Study Completion
September 1, 2004
Last Updated
August 19, 2015
Results First Posted
June 22, 2010
Record last verified: 2015-08