A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
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...
Brief Summary
Official Title: “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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2003
Intervention(s) in this Clinical Trial
- Drug: Comparator: Treatment A (Zofran, ondansetron)
- an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
- Drug: Comparator: Treatment B (Zofran, ondansetron)
- a single 8 mg tablet of Zofran marketed in the U.K., taken PO
- Drug: Comparator: Treatment C (Zofran, ondansetron)
- a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Treatment Sequence A-B-C
- Experimental: 2
- Treatment Sequence B-C-A
- Experimental: 3
- Treatment Sequence C-A-B
- Experimental: 4
- Treatment Sequence A-C-B
- Experimental: 5
- Treatment Sequence B-A-C
- Experimental: 6
- Treatment Sequence C-B-A
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: No
- Time Frame: 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
Safety Issue?: No
- Time Frame: 24 hours post dose
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00971633
Study ID Number: 2009_656
ClinicalTrials.gov Identifier: NCT00971633
Health Authority: United States: Food and Drug Administration
MedWatch - FDA maintained medical product safety Information
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00971633
