A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to establish bioequivalence of paliperidone ER tablets manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville, administered as a single dose of 12 mg under fasted conditions to healthy male volunteers, and to assess the safety and tolerability of both formulations.

• 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:

• Must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

• Body mass index (weight [kg]/height [m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg

• Blood pressure (after the patient is supine for 5 minutes) between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic

• Non-smoker

Exclusion Criteria:

• History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer

• History of any cancer, with the exception of basal cell carcinoma

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center

• Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening or at admission to the study center

• At screening, has signs of autonomic dysfunction as indicated by a 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 <40 bpm) as determined by screening 12-lead ECG

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) or ibuprofen, within 14 days before the first dose of the study drug is scheduled

• History of, or a reason to believe a volunteer has a history of, drug or alcohol abuse and/or dependence within the past 5 years

• Known history of drug-induced dystonia or Neuroleptic Malignant Syndrome

• Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies

• History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or volunteer's verbal report