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Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia

NCT06276361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-09-08

No results posted yet for this study

Summary

This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia.

Conditions

Interventions

DRUG

Oral risperidone; QUAR F1/2, Dose 1 - Gluteal

Dose level 1

DRUG

Oral risperidone; QUAR F1/2, Dose 2 - Gluteal

Dose level 2

DRUG

Oral risperidone; QUAR F1/2, Dose 3 - Gluteal

Dose level 3

DRUG

Oral risperidone; QUAR F1/2, Dose 3 - Deltoids

Dose level 3

Sponsors & Collaborators

  • Rovi Pharmaceuticals Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2025-07-07
Completion
2025-07-07

Countries

  • Jordan

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 NCT06276361 on ClinicalTrials.gov