Status:
COMPLETED
A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
The purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety and tolerability.
Detailed Description
This study was designed as a randomized, open-label, single-center, crossover study to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanes...
Eligibility Criteria
Inclusion
- Japanese volunteers must have been born in Japan of Japanese parents and not lived outside of Japan for more than 5 years
- Female volunteers must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study, have a negative serum beta-HCG pregnancy test at screening and a negative urine pregnancy test on Day -1
- Volunteers must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Volunteers must sign informed consent document for pharmacogenomic testing
- However, participation in the genetic testing component is not mandatory for participation in the remainder of the study
- Volunteers must have a weight as defined by Body Mass Index or Quetelet Index (weight \[kg\]/height (m)²) within the range of 18.0 - 25.0, extremes included and must be normotensive with supine (5 min) blood pressure between the range of 100-139 mm Hg systolic and 60-89 mm Hg diastolic
- Volunteers must be healthy on the basis of a pre-study physical examination, medical history, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 3 weeks before the first dose. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only on condition that the investigator judges that the deviations are not clinically significant. For liver function tests (AST, ALT, bilirubin) the values must be within 2 times the upper limit of the normal reference ranges
- Volunteers must smoke less than 10 cigarettes per day and agree not to change smoking habits during the study
Exclusion
- Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, psychiatric, or immunologic disorders
- History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- Inability to swallow study medication (volunteers may not chew, divide, dissolve, or crush the study medication)
- History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse
- Drug allergy to risperidone, paliperidone or any of its excipients
- Use of concomitant medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) and hormonal contraceptives. All other medication must have been stopped at least 14 days before the first dose in the study
- At screening, 2 and 3 minutes after standing, experience a decrease of greater than or equal to 20 mmHg systolic blood pressure, a decrease of greater than or equal to 10 mmHg diastolic blood pressure, or an increase of greater than or equal to 20 beats per minute in heart rate or with symptoms of lightheadedness, dizziness, or fainting upon standing from the supine position
- Positive serology tests for hepatitis B, C or HIV
- Female volunteers that are pregnant, nursing, or planning to become pregnant
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00892320
Start Date
March 1 2004
End Date
May 1 2004
Last Update
June 8 2011
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