A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers
NCT00892320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2011-06-08
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.
Conditions
Interventions
- DRUG
-
ER OROS paliperidone
Sponsors & Collaborators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Completion
- 2004-05-31
More Related Trials
-
A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia
NCT01258920 ·Status: COMPLETED ·Phase: PHASE3
-
As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations
NCT00796185 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function
NCT00791401 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
NCT00791232 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetics and Pharmacodynamics Study Under Fasting and Fed Conditions With Paliperidone Extended-release and Immediate-release Formulations
NCT00796640 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release Paliperidone
NCT00796276 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder
NCT00892125 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia
NCT00350467 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
NCT00796081 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Potential Effects of Trimethoprim on the Pharmacokinetics of ER OROS Paliperidone
NCT00892541 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Effects of Paroxetine on the Pharmacokinetics of Paliperidone ER
NCT00791713 ·Status: COMPLETED ·Phase: PHASE1
-
A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
NCT00645307 ·Status: COMPLETED ·Phase: PHASE3
-
A Dose-proportionality Study of Five Tablet Strengths of ER OROS Paliperidone
NCT00796835 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Study of the Relative Bioavailability of Paliperidone ER Formulations With Different Release Profiles and a Comparison to Paliperidone IR
NCT00791193 ·Status: COMPLETED ·Phase: PHASE1
-
A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia
NCT00650793 ·Status: COMPLETED ·Phase: PHASE3
-
A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia
NCT01606254 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
NCT00086320 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
NCT00397033 ·Status: COMPLETED ·Phase: PHASE3
-
24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
NCT00752427 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
NCT01942382 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
NCT00412373 ·Status: COMPLETED ·Phase: PHASE3
-
Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia
NCT00073320 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
NCT00791284 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Dose Proportionality of Extended Release Paliperidone
NCT00791167 ·Status: COMPLETED ·Phase: PHASE1
-
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
NCT00257023 ·Status: COMPLETED ·Phase: PHASE2