Status:
COMPLETED
Study Evaluating and Comparing Single Dose and Multiple Dose Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Adults.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study was to evaluate and compare the pharmacokinetics of ER OROS paliperidone in healthy Japanese and Caucasian patients.
Detailed Description
This was a randomized (study medication assigned by chance), double blind (neither physician or patient knows the name of the study medication/placebo assigned) study comparing the single does (SD) an...
Eligibility Criteria
Inclusion
- Healthy Japanese and Caucasian patients. Japanese patients had to be born in Japan of Japanese parents and not to have lived outside of Japan for more than 5 years
- Normotensive (5 minute lying down systolic blood pressure of 100-139 mmHg and diastolic blood pressure of 60-89 mmHg)
- Body Mass Index of 18 to 25 kg/m2
- Considered healthy based on medical history, prestudy physical examination findings, electrocardiogram, and clinical laboratory evaluation of chemistry, hematology, and urinalysis values.
Exclusion
- History of any significant cardiovascular, respiratory, neurologic, renal, hepatic, endocrine, psychiatric, or immunologic disorders
- Use of concomitant medication, except for paracetamol and hormonal contraceptives
- Has received an experimental drug and/or used an experimental medical device in the 60 days before the first dose.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00758030
Start Date
March 1 2004
End Date
July 1 2004
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.