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

Conditions: /A
pharmacokinetic study.Methylphenidate is indicated in ADHD and narcolepsia.

Registration Number: EUCTR2010-020014-28-NL

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ?To establish the pharmacokinetic profiles of saliva and plasma concentration of 10 mg MPH-IR and 18 mg MPH-OROS in healthy volunteers.<br>?To investigate whether there is a correlation between saliva- and plasma levels of MPH-IR and MPH-OROS, and if present, to describe this relationship. <br>?To determine the effect of saliva pH on MPH saliva concentration.<br>;Secondary Objective: ?To explore the potential influence of a hCE1A1 (human carboxylesterase 1A1) polymorphism on the plasma concentration time profile of MPH. If indicated, polymorphisms of regulator enzymes, like nuclear receptor enzymes, will also be explored in the future.;Primary end point(s): ?Saliva ADHD medication concentrations (and effect of saliva pH)<br>?Plasma ADHD medication concentrations<br>?Relationship between measured saliva and plasma concentrations<br>

Secondary Outcome Measures