Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00796185
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-11-20
Brief Title:
As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Comparison of Steady-state Pharmacokinetics of Paliperidone After Extended-release OROS Paliperidone 15 mg and Immediate-release Oral Risperidone 8 mg bid in Subjects With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the steady-state pharmacokinetics of paliperidone after oral administration of 15 mg extended-release ER OROS paliperidone once daily with the steady-state pharmacokinetics of paliperidone after oral administration of 8 mg immediate-release IR risperidone twice daily and to explore the dose-proportionality of 9 mg and 15 mg ER OROS paliperidone Other objectives are to 1 document the disposition of the enantiomers of paliperidone 2 explore the relationship between genotype CYP2D6 CYP3A4 CYP3A5 UGT1A1 and UGT1A6 and pharmacokinetic parameters and 3 assess safety and tolerability
Detailed Description:
This is an open-label multiple-dose parallel-group study in patients with schizophrenia or schizoaffective disorder The study consists of a screening period 2 weeks maximum a 1-week run-in or washout Days 1 to 7 during which patients taking risperidone prestudy and randomly assigned to paliperidone treatment will receive replacement antipsychotic therapy and other patients continue to take their prestudy antipsychotic medication a 14-day open-label treatment period Days 8 to 21 and a 5-day follow-up period On Day 1 of the washout period eligible patients will be randomized to receive ER OROS paliperidone PAL or risperidone RIS All patients will receive their first dose of study medication on Day 8 after randomization as follows Patients randomized to PAL will receive 9 mg of ER OROS paliperidone daily from Day 8 to Day 14 followed by 15 mg of ER OROS paliperidone qd from Day 15 to Day 21 Patients randomized to RIS will receive dose-escalation up to 7 mg risperidone twice daily bid from Day 8 to Day 14 followed by 8 mg risperidone bid from Day 15 to Day 21 The study medication on Days 14 and 21 in the PAL group and on Day 21 in the RIS group will be administered after completion of a standardized high fat high caloric breakfast Patients will be confined to the testing facility from the morning of Day 8 or earlier at the discretion of the investigator until completion of the study procedures on Day 23 On all other assessment days patients will return to the testing facility and remain there for the duration of the assessmentsThe highest dose of paliperidone currently being studied is 12 mg given as 6 tablets of 2 mg ER OROS paliperidone In the currently proposed study data on the safety and tolerability of the 15-mg dose will be monitored and collected Paliperidone ER oral administration of 9 mg qd on Day 8 to 14 and 15 mg daily on Day 15 to 21 oral administration of escalating doses up to 7 mg risperidone twice daily bid between Days 8 and 14 inclusive and 8 mg risperidone bid on Day 15 to 21
Study Oversight
Has Oversight DMC:
None
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?:
None