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

NCT00971633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-09-14

Study results available
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Summary

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.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

Comparator: Treatment A (Zofran, ondansetron)

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

DRUG

Comparator: Treatment B (Zofran, ondansetron)

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

DRUG

Comparator: Treatment C (Zofran, ondansetron)

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2003-12-31
Completion
2004-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00971633 on ClinicalTrials.gov