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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: Completed Phase 1 study, sponsored by Zogenix.

NCT01592110 is a Phase 1 study that has completed, run by Zogenix. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Zogenix

9 total trials

What the finished NCT01592110 record still lists

NCT01592110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

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

NCT01592110 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01592110's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01592110, the US trial registry maintained by the National Library of Medicine. NCT01592110 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.