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Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

NCT01217190 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-07-29

Study results available
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Summary

This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.

Conditions

  • Nausea and Vomiting, Postoperative
  • Nausea With Vomiting Chemotherapy-Induced

Interventions

DRUG

Ondansetron (ODFS)

Test Article

DRUG

Zofran (ODT)

Comparator

Sponsors & Collaborators

  • MonoSol Rx

    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
2008-09-16
Primary Completion
2008-09-26
Completion
2008-10-06

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 NCT01217190 on ClinicalTrials.gov