Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®

Summary

The study will comprise two dosing periods in two different cohorts of healthy volunteers. The investigators will begin with a single dosage period I (1 injection of 25 mg of Risperidone for each subject); single dosage period II, different from the previous one (1 injection of 37.5 mg of Risperidone for each subject), in a second group of healthy volunteers different from the first group will not start until after a preliminary analysis has been made of the safety data and plasma concentration data are known for the formulation of prolonged release Risperidone using the ISM® technology.

Timeline

Start

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Primary completion

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Completion

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Drugs

Indications

No indication recorded.