MedTrace Logo

Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers

NCT01572012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-01-24

No results posted yet for this study

Summary

This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

Ondansetron

Ondansetron solution 4 mg single administration

DRUG

Ondansetron + Hylenex

Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration

DRUG

Zofran ODT

Zofran ODT (8 mg) single administration

DRUG

Ondansetron solution

Ondansetron solution (4 mg) single administration

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Samuel S Dychter, MD · Halozyme Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01572012 on ClinicalTrials.gov