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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: Treatment A (Zofran, ondansetron)

Drug

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

Other names: Zofran, ondansetron

Comparator: Treatment B (Zofran, ondansetron)

Drug

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

Other names: Zofran, ondansetron

Comparator: Treatment C (Zofran, ondansetron)

Drug

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

Other names: Zofran, ondansetron

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2004
First posted: Sep 4, 2009
Registry last updated: Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed