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

Merck Sharp & Dohme LLC12 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy-Induced Nausea and Vomiting

Interventions

Comparator: Treatment A (Zofran, ondansetron)DRUG

an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)

Comparator: Treatment B (Zofran, ondansetron)DRUG

a single 8 mg tablet of Zofran marketed in the U.K., taken PO

Comparator: Treatment C (Zofran, ondansetron)DRUG

a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Maximum Plasma Concentration (Cmax) of Ondansetron

Time frame: 24 hours post dose

Data from ClinicalTrials.gov

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