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

NCT01320410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-05-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ISM®

Sponsors & Collaborators

  • Rovi Pharmaceuticals Laboratories

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320410 on ClinicalTrials.gov