Pharmacokinetics in Plasma and Saliva of a Single Dose Immediate- or Extended-Release Methylphenidate in Healthy Volunteers.
Completed
- Conditions
- ADHDattention-deficit/hyperactivity disorder (PK study)10009841
- Registration Number
- NL-OMON34088
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
18-35 years of age
BMI 18-30 kg/m2, body weight 50-90 kg
Healthy
Exclusion Criteria
Pregancy or breast feeding
Alcohol or substance abuse
Smoking > 5 cig/day
Previous exposure to stimulant compounds past 6 months
Disallowed concomittant medication within one week from first study day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Saliva methylphenidate concentrations (and effect of saliva pH); plasma<br /><br>methylphenidate concentrations; relationship between measured saliva and plasma<br /><br>concentrations</p><br>
- Secondary Outcome Measures
Name Time Method <p>Relationship between hCE1 (and other nuclear enzymes) polymorphism(s) and<br /><br>methylphenidate clearance. </p><br>