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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Paliperidone ER

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Paliperidone ER, Schizophrenia, Mood disorders, Antipsychotic drugs

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

To establish bioequivalence of paliperidone ER tablets manufactured at Gurabo compared with paliperidone ER tablets manufactured at Vacaville, administered as a single oral dose of 12 mg under fasted conditions

Secondary Outcome Measures

To asses the safety and tolerability of both formulations

Full Information

NCT ID

NCT00790777

First Posted

November 13, 2008

Last Updated

May 17, 2011

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00790777

Brief Title

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

Official Title

A Single-dose, Open-label, Randomized, 2-way Crossover Pivotal Bioequivalence Study of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville Under Fasted Condition in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

5. Study Description

Brief 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.

Detailed Description

This is a randomized, open-label, 2-way crossover study in healthy male adults.The study consists of a screening phase and an open label treatment phase during which each patient will receive the 2 treatments of the study drug separated by a washout period of 7 to 14 days. Treatment A will consist of a single oral dose of 12-mg paliperidone ER, tablets manufactured at Gurabo, administered under fasted condition. Treatment B will consist of a single oral dose of 12-mg paliperidone ER, tablets manufactured at Vacaville, administered under fasted condition. Blood samples for pharmacokinetic analysis will be collected at pre-dose and for 96 hours post-dose for each period. As a change in manufacturing site will take place, bioequivalence between 12 mg tablets (highest dose strength) from the 2 production sites (Gurabo [Puerto Rico, USA] and Vacaville [California, USA]) needs to be demonstrated. This pivotal bioequivalence study is designed to examine the pharmacokinetics, safety, and tolerability of paliperidone ER manufactured at Gurabo in comparison with paliperidone ER manufactured at Vacaville Two single oral doses of paliperidone ER 12 mg

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Paliperidone ER, Schizophrenia, Mood disorders, Antipsychotic drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Paliperidone ER

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

To asses the safety and tolerability of both formulations

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Organizational Affiliation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=741&filename=CR012085_CSR.pdf

Description

A study of the bioequivalence of 12 mg paliperidone extended release tablets manufactured at Gurabo and Vacaville

Learn more about this trial

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

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