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NCT01572012 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers
A Phase 1 study, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01572012 is a Phase 1 study that has completed, run by Halozyme Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT01572012, a Phase 1 study, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
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.
Interventions
- DRUG Ondansetron
- DRUG Ondansetron + Hylenex
- DRUG Zofran ODT
- DRUG Ondansetron solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572012
The ClinicalTrials.gov registry entry for NCT01572012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.
NCT01572012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01572012 about?
NCT01572012 is a clinical study titled "Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers". 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.
What is the current status of trial NCT01572012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-02. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01572012?
The interventions under investigation include: Ondansetron (DRUG), Ondansetron + Hylenex (DRUG), Zofran ODT (DRUG), Ondansetron solution (DRUG).
Who is sponsoring clinical trial NCT01572012?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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