Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT00892320
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2010-04
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 purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety and tolerability.
Detailed Description:
This study was designed as a randomized, open-label, single-center, crossover study to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults. Of the 20 Japanese volunteers who are to be enrolled, at least 6 are to be men and 6 are to be women. All volunteers will receive single doses of 3 mg ER OROS paliperidone with and without a standard Japanese breakfast. There will be a 1-week washout between treatments, for a total treatment duration of approximately 2 weeks. Volunteers are to be randomly assigned to 1 of 2 treatment sequence groups (fed and fasted; fasted and fed). The pharmacokinetics of paliperidone will be assessed for 96 hours after each dosing. Safety and tolerability will be monitored throughout the study. Prior to initiating clinical trials in Japan, a food effect study is required to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in Japanese adults.
3 mg tablets, single oral dose, once under fasting and once under fed conditions
3 mg tablets, single oral dose, once under fasting and once under fed conditions
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: