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Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

NCT01220167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-08-18

Study results available
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Summary

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

Conditions

  • Healthy Participants

Interventions

DRUG

Ondansetron 8 mg ODFS without water

Single dose of Ondansetron 8 mg (ODFS) administered without water

DRUG

Ondansetron 8 mg ODFS with water

Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water

DRUG

Zofran ODT (ondansetron 8 mg) without water

Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water

Sponsors & Collaborators

  • Aquestive Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sudershan Vishwanath, MD · Vimta Labs Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-08-31
Completion
2008-08-31

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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 NCT01220167 on ClinicalTrials.gov