Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerance of Single Dose Administration of a New Injectable Prolonged Release Formulation of Risperidone Using ISM® Technology in Healthy Volunteers|
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