A Bioequivalence Study of 15 mg ER OROS Paliperidone

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the bioequivalence between the Phase 3 and the to-be-marketed formulations of extended release (ER) OROS paliperidone and to evaluate the effect of food on the highest to be marketed tablet strength. Additionally, the safety and tolerability of the treatments in healthy volunteers will be assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Body Mass Index (weight [kg]/height [m²]) of 18 to 28 kg/m², inclusive

• Have a supine (after 5 minutes rest) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 50 to 90 mmHg diastolic, inclusive

• Healthy on the basis of a prestudy physical examination, medical history, 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:

• Drug allergy to risperidone, paliperidone, or any of its excipients

• Known allergy or history of significant hypersensitivity to heparin, in case a heparin lock will be used

• Recent history of alcohol or substance abuse, a positive test result for the urine drug screen at screening or upon admittance to the testing facility or a positive result for the alcohol urine test upon admittance to the testing facility

• 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 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 ECG

• History of or a positive test result for any of the serology tests (hepatitis B, C, and HIV)

• 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