drugset / Trial / NCT06276361

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

NCT06276361

Phase 1 Completed 58 enrolled Rovi Pharmaceuticals Laboratories
RandomizedSequentialOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified Oral

Indications