Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00791193
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2008-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of the Relative Bioavailability of Paliperidone ER Formulations With Different Release Profiles and a Comparison to Paliperidone IR
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
Pharmacokinetic Evaluation of the Relative Bioavailability of Three Paliperidone Extended Release (ER) Formulations With Different in Vitro Release Profiles, and Comparison to Paliperidone Immediate Release (IR), in Healthy Male 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 primary purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of paliperidone ER formulations with slow, target, and fast in vitro release rates after administration of a single 12 mg dose. The slow and fast releasing ER tablets have in vitro release rates outside the current commercial specifications. Therefore, in order to support widening of the specification limits, this study will be performed. The target formulation to be used is representative of the commercial formulation. Other objectives of this study are 1) to compare the relative bioavailability of paliperidone ER formulations with slow, target, and fast in vitro release rates to the paliperidone IR formulation; 2) to explore the in vitro in vivo correlation (IVIVC) for the paliperidone ER formulation; and 3) to evaluate the safety and tolerability of the different paliperidone ER formulations.
Detailed Description:
This is a randomized, open-label, 4-way crossover, single dose study in healthy male volunteers to evaluate the pharmacokinetic profiles of paliperidone ER tablets with slow, target, and fast in vitro release rates and paliperidone IR. The study consists of a 21 day screening phase, an open-label treatment phase consisting of 4 single-dose treatment periods (IR, slow, fast, and target formulations), and an end-of-study or early withdrawal phase. A 10- to 21 day washout period (i.e., \>5 times the half-life) will separate each study drug administration (i.e., each open label treatment period). In the first period, all volunteers are given a 1-mg dose of paliperidone IR solution, administered as a single oral dose under fasted conditions (Treatment A). On Day 1 of Period 2, prior to study drug administration, all volunteers will be randomly assigned to 1 of 6 possible treatment sequences to ensure that they receive all of the following treatments, one in each period: 12-mg paliperidone ER tablet with a target in vitro release under fasted condition (Treatment B); 12-mg paliperidone ER tablet with a slow in vitro release under fasted condition (Treatment C); 12-mg paliperidone ER tablet with a fast in vitro release under fasted condition (Treatment D). In each treatment period, volunteers will enter the study center at least 10 hours before the study drug administration on Day 1 and will remain there until after collection of the 96 hour pharmacokinetic samples on Day 5 if the investigator considers that the volunteer is ready for discharge. It is expected that the differences in the in vitro release rate will not affect the relative bioavailability of paliperidone in vivo. Safety and tolerability of the different paliperidone ER formulations will be monitored throughout the study.
Single oral doses of paliperidone ER 12 mg tablets with different release rates (target, fast, and slow); single oral dose of paliperidone IR 1 mg
Single oral doses of paliperidone ER 12 mg tablets with different release rates (target, fast, and slow); single oral dose of paliperidone IR 1 mg
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?: