A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
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* Drug: Comparator: Treatment A (Zofran, ondansetron)
* Drug: Comparator: Treatment B (Zofran, ondansetron)
* Drug: Comparator: Treatment C (Zofran, ondansetron)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment Sequence A-B-C | Drug: Comparator: Treatment A (Zofran, ondansetron)<br>* an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment B (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the U.K., taken PO<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment C (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO<br>* Other names: Zofran, ondansetron;|
| Experimental: 2<br>Treatment Sequence B-C-A | Drug: Comparator: Treatment A (Zofran, ondansetron)<br>* an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment B (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the U.K., taken PO<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment C (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO<br>* Other names: Zofran, ondansetron;|
| Experimental: 3<br>Treatment Sequence C-A-B | Drug: Comparator: Treatment A (Zofran, ondansetron)<br>* an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment B (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the U.K., taken PO<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment C (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO<br>* Other names: Zofran, ondansetron;|
| Experimental: 4<br>Treatment Sequence A-C-B | Drug: Comparator: Treatment A (Zofran, ondansetron)<br>* an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment B (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the U.K., taken PO<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment C (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO<br>* Other names: Zofran, ondansetron;|
| Experimental: 5<br>Treatment Sequence B-A-C | Drug: Comparator: Treatment A (Zofran, ondansetron)<br>* an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment B (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the U.K., taken PO<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment C (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO<br>* Other names: Zofran, ondansetron;|
| Experimental: 6<br>Treatment Sequence C-B-A | Drug: Comparator: Treatment A (Zofran, ondansetron)<br>* an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment B (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the U.K., taken PO<br>* Other names: Zofran, ondansetron;Drug: Comparator: Treatment C (Zofran, ondansetron)<br>* a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO<br>* Other names: Zofran, ondansetron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron |  | 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 |  | 24 hours post dose |