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More info
You can access this
clinical trial
if you have
Healthy
and you are
between 18 and 50
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: ISM®

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01320410. The sponsor of the trial is Rovi Pharmaceuticals Laboratories and it is looking for 0 volunteers for the current phase.
Official trial 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