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Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia - Trial NCT06276361

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.

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NCT06276361
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06276361
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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)

Study Focus

Schizophrenia

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

Interventional

drug

Sponsor & Location

Rovi Pharmaceuticals Laboratories

Amman, Jordan

Timeline & Enrollment

Phase 1

Sep 26, 2023

May 01, 2026

100 participants

Primary Outcome

ฮปz,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

Schizophrenia
Simple schizophrenia
Schizophrenia, unspecified
Other schizophrenia
Paranoid schizophrenia

Data Source

ClinicalTrials.gov

NCT06276361

Non-Device Trial