NCT01788774

Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths

Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Rovi Pharmaceuticals Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

Detailed description

This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population. Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug: Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Risperidone ISM 50 mg
DRUG	Risperidone ISM 75 mg
DRUG	Risperidone ISM 100 mg

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-02-11
• Last updated: 2023-10-23

Locations

5 sites across 4 countries: Croatia, Russia, South Africa, Spain