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NCT06276361

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

A Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Injection of Quarterly Risperidone (QUAR) for Different Formulations and Dose Strengths in Participants With Schizophrenia (QUARTZ Study)
Rovi Pharmaceuticals Laboratories·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Schizophrenia
Drug/Device/Intervention
Oral risperidone; QUAR F1/2, Dose 1 - Gluteal
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Rovi Pharmaceuticals Laboratories
Location
Amman, Jordan
Timeline & enrollment
Phase
Phase 1
Start date
Sep 26, 2023
End date
May 01, 2026
Enrollment
100 participants
Primary outcome

λz,t1/2,Tmax,Cmax,Cmin,Clast,AUC0-t,AUCinf,AUCextrap,Vd/F,Cl/F

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.

ICD-10 classifications
SchizophreniaSimple schizophreniaSchizophrenia, unspecifiedOther schizophreniaParanoid schizophrenia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06276361
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06276361 through Pure Global AI's free database. This Phase 1 trial is sponsored by Rovi Pharmaceuticals Laboratories and is currently Recruiting. The study focuses on Schizophrenia. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.