A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
September 13, 2016 updated by: Merck Sharp & Dohme LLC
An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Treatment Sequence A-B-C
|
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Names:
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Names:
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Names:
|
|
Experimental: 2
Treatment Sequence B-C-A
|
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Names:
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Names:
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Names:
|
|
Experimental: 3
Treatment Sequence C-A-B
|
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Names:
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Names:
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Names:
|
|
Experimental: 4
Treatment Sequence A-C-B
|
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Names:
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Names:
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Names:
|
|
Experimental: 5
Treatment Sequence B-A-C
|
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Names:
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Names:
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Names:
|
|
Experimental: 6
Treatment Sequence C-B-A
|
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Names:
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Names:
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
|
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
|
|
Maximum Plasma Concentration (Cmax) of Ondansetron
Time Frame: 24 hours post dose
|
24 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
December 1, 2003
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
September 3, 2009
First Submitted That Met QC Criteria
September 3, 2009
First Posted (Estimate)
September 4, 2009
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 13, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- 0869-095
- 2009_656
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.