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 个研究点目标入组 12 人开始时间: 2010年4月20日最近更新: 2012年3月19日

适应症

试验速览

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•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;

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