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

NCT00972595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-08-19

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 non-U.S. marketed formulation of ondansetron.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting

Interventions

DRUG

ondansetron clinical trial formulation

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

DRUG

ondansetron marketed formulation

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

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
2004-06-30
Primary Completion
2004-08-31
Completion
2004-09-30

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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 NCT00972595 on ClinicalTrials.gov