Trials / Completed
CompletedNCT01320410
Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Rovi Pharmaceuticals Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISM® |
Timeline
- First posted
- 2011-03-22
- Last updated
- 2014-05-01
Source: ClinicalTrials.gov record NCT01320410. Inclusion in this directory is not an endorsement.