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

NCT01592110 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-10

No results posted yet for this 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.

Conditions

Interventions

DRUG

risperidone-SABER

25 mg of risperidone-SABER administered as a subcutaneous (SC) injection of 0.25 mL

OTHER

ZX003:risperidone-SABER and the DosePro System

50 mg risperidone-SABER administered as 0.5 mL via the DosePro Needle-Free Injection System

DRUG

risperidone-SABER

50 mg of risperidone-SABER administered as a SC injection of 0.5 mL

DRUG

Risperidone-SABER

100 mg of risperidone-SABER administered as a SC injection of 1.0 mL

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • Lev G Gertsik, MD · Parexel

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01592110 on ClinicalTrials.gov