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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chemotherapy-Induced Nausea and Vomiting

Treatments: Drug: ondansetron clinical trial formulation; Drug: ondansetron marketed formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972595

MK0869-106

0869-106

2009_657

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

A

Experimental group

Description:

clinical trial formulation

Treatment:

Drug: ondansetron clinical trial formulation

B

Active Comparator group

Description:

non-U.S. marketed formulation

Treatment:

Drug: ondansetron marketed formulation