Status:
COMPLETED
A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Eligibility:
MALE
20-35 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of Methylphenidate HCl in healthy Japanese adult male volunteers.
Detailed Description
This is an open-label (name of assigned treatment is known), single-center study of the pharmacokinetics (blood levels) and safety of 3 single doses of methylphenidate HCl administered orally (by mout...
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive
- Body weight of not less than 50 kg
- Supine (lying down) blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic
Exclusion
- History of or current medical illness judged by the investigator to be clinically significant
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of study drug
- History of drug or alcohol abuse within the past 5 years
- History of smoking or use of nicotine containing substances within the previous 2 months
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01202734
Start Date
September 1 2010
End Date
November 1 2010
Last Update
May 16 2014
Active Locations (1)
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1
Cypress, California, United States