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Two Way Bioequivalence Study Under Fed Conditions

NCT01217801 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-05-02

Study results available
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Summary

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.

The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Ondansetron (ODFS)

Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)

DRUG

Ondansetron (ODT)

Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)

Sponsors & Collaborators

  • MonoSol Rx

    lead INDUSTRY

Principal Investigators

  • Sudershan Vishwanath · Vimta VHS Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • India

Study Locations

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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 NCT01217801 on ClinicalTrials.gov