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A Study of the Dose Proportionality of Extended Release Paliperidone

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ClinicalTrials.gov Identifier: NCT00791167
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : May 18, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone ER Phase 1

Detailed Description:

This is a randomized, open label, single center, single dose, 2 treatment, 2 way crossover study. It consists of 3 phases: A screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2) during which volunteers will receive a single oral 1.5 or 3 mg dose of study drug; and end of study evaluations upon completion of all the study procedures in Period 2. All volunteers will receive each of the following 2 treatments in random order: Treatment A: One tablet of 1.5 mg paliperidone ER to-be-marketed formulation in the fasted state; Treatment B: One tablet of 3 mg paliperidone ER Phase 3 formulation in the fasted state. Successive study drug administrations will be separated by a washout period of at least 9 days and no more than 21 days. A 1.5-mg dose of paliperidone ER was selected to be studied as the availability of a 1.5-mg tablet would make dose-adjustments across the existing range of doses of paliperidone ER easier in patients with reduced renal function or tolerability issues. Safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men will be monitored throughout the study.

A single oral doses of 1.5 mg and 3 mg paliperidone ER

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Dose Proportionality of Two Dose Strengths (1.5 and 3 mg) of Extended-release Paliperidone After a Single Administration to Healthy Men
Study Start Date : June 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. To evaluate dose-proportionality of 1.5 and 3-mg tablets of paliperidone ER

Secondary Outcome Measures :
  1. To document the pharmacokinetics of a 1.5-mg dose of paliperidone ER in healthy men and to assess the safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body mass index ( weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
  • Have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
  • Healthy on the basis of a prestudy physical examination, medical history, 12-lead ECG, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. If the results of the serum chemistry, hematology, or urinalysis testing are not within the laboratory's reference ranges, the volunteer can be included only if the investigator judges that the deviations are not clinically significant. For renal function tests, the values must be within the normal laboratory reference ranges

Exclusion Criteria:

  • Known drug allergy to risperidone, paliperidone, or any of its excipients
  • Known history of drug-induced dystonia
  • Recent history of alcohol or substance abuse
  • Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
  • History of any cancer, with the exception of basal cell carcinoma
  • At screening, has signs of autonomic dysfunction as indicated by a sustained decrease of > 20 mmHg in systolic blood pressure or a decrease of >10 mmHg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
  • Bradycardia (heart rate <50 bpm) as determined by screening 12-lead ECG
  • A positive test result (or history of) for any of the serology tests (hepatitis B and C, and human immunodeficiency virus) at screening
  • History of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. Volunteers must agree to refrain from use throughout the study
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of study drug. Exception for acetaminophen (paracetamol) or ibuprofen, which is allowed up to 3 days before first dose of study drug
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791167

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00791167     History of Changes
Other Study ID Numbers: CR011437
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: February 2009

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Mood Disorders, Antipsychotic drugs
Paliperidone ER

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents