Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
NCT01774435 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2014-11-03
Summary
This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation durations of 6 months.
Conditions
Interventions
- DRUG
-
EN3342
Sponsors & Collaborators
-
Endo Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Robert Litman, MD · CBH Health LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2013-10-31
- Completion
- 2013-10-31
Countries
- United States
Study Locations
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