Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)

Merck Sharp & Dohme LLC45 enrolled

Overview

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy-Induced Nausea and Vomiting

Interventions

ondansetron clinical trial formulationDRUG

Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.

ondansetron marketed formulationDRUG

Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.

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 has been a nonsmoker for at least 6 months * Subject is in good health Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron

Time frame: 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

Time frame: 24 hours post-dose

Data from ClinicalTrials.gov

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