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

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 Overview

• Status: Completed
• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Intervention / Treatment: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (Estimate): September 4, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: 0869-095; 2009_656