A Study of the Dose Proportionality of Extended Release Paliperidone
NCT00791167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2011-05-18
Summary
The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.
Conditions
Interventions
- DRUG
-
Paliperidone ER
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
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-06-30
- Completion
- 2006-08-31
More Related Trials
-
Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia
NCT00334126 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia
NCT01541371 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
NCT00524043 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
NCT01577160 ·Status: COMPLETED ·Phase: PHASE4
-
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
-
Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia
NCT00590577 ·Status: COMPLETED ·Phase: PHASE3
-
A Pharmacokinetics and Pharmacodynamics Study Under Fasting and Fed Conditions With Paliperidone Extended-release and Immediate-release Formulations
NCT00796471 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
NCT00757705 ·Status: COMPLETED ·Phase: PHASE4
-
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
NCT00761189 ·Status: COMPLETED ·Phase: PHASE4
-
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
-
As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations
NCT00796185 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
NCT01009047 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating and Comparing Single Dose and Multiple Dose Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Adults.
NCT00758030 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioequivalence Study of 15 mg ER OROS Paliperidone
NCT00892489 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
NCT00535145 ·Status: COMPLETED ·Phase: PHASE4
-
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
NCT00257023 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia
NCT00210717 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia
NCT01150448 ·Status: COMPLETED ·Phase: PHASE1
-
A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.
NCT00668837 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia
NCT00085748 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate
NCT01110317 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia
NCT01662310 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia
NCT00210548 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville
NCT00790777 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia
NCT00074477 ·Status: COMPLETED ·Phase: PHASE2