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NCT01592110 · ClinicalTrials.gov registry record · Phase 1

A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia

A Phase 1 study, sponsored by Zogenix.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT01592110 is a Phase 1 study that has completed, run by Zogenix. The registered enrollment target is 40 participants.

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The verdict

NCT01592110, a Phase 1 study, has completed, sponsored by Zogenix.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.

Interventions

  • DRUG risperidone-SABER
  • OTHER ZX003:risperidone-SABER and the DosePro System
  • DRUG Risperidone-SABER

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2012-07
Est. Completion 2013-04
Phase Phase 1

Sponsor

Zogenix

9 total trials

What the Registry Record Tells You About NCT01592110

The ClinicalTrials.gov registry entry for NCT01592110 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which risperidone-SABER is the first listed.

NCT01592110 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01592110 about?

NCT01592110 is a clinical study titled "A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia". This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.

What is the current status of trial NCT01592110?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-07. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01592110?

The interventions under investigation include: risperidone-SABER (DRUG), ZX003:risperidone-SABER and the DosePro System (OTHER), Risperidone-SABER (DRUG).

Who is sponsoring clinical trial NCT01592110?

This trial is sponsored by Zogenix, which has 9 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.