Pharmacokinetics in Plasma and Saliva of a Single Dose Immediate- or Extended Release Methylphenidate in Healthy Volunteers. - MPH PK in adults.

Centre for Human Drug Research0 sites12 target enrollmentApril 20, 2010

Overview

No summary available.

Registry

who.int

Start Date

April 20, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Subject must be 18\-35 years of age (inclusive)
•2\.Subject has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive);
•3\.Subject is able to read and understand the written consent form, complete study\-related procedures, and communicate with the study staff;
•4\.Subject is willing to comply with study restrictions;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•5\.Breast feeding (females only);
•6\.History of alcoholism or substance abuse within three years prior to screening;
•7\.Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week;
•8\.Positive drug or alcohol test at screening and/or admission (Day 1\);
•9\.Subject is a smoker (\> 5 cigarettes per day) or has used nicotine/nicotine\-containing products within 3 months prior to screening;
•10\.Subject has previous exposure to stimulant drugs (including but not limited to MPH, MDMA, metamphetamine, amphetamine, ephedrine or cocaine) or substances in the past 6 months;
•11\.Subject is unable to refrain from the use of disallowed concomitant medication (as described in paragraph 3\.4\) from one week prior to the first study drug administration until the post study visit;
•12\.Subject is unable to refrain from food and drinks containing a xanthine (e.g. chocolate, cola, coffee or tea) during the study days;