Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-28 @ 6:50 PM
Study NCT ID:
NCT01774435
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2013-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Sponsor:
Endo Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH) Risperidone When Risperidone is Administered From a Polyurethane Implant
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation durations of 6 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: