Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

February 28, 2007

Study Completion Date

February 29, 2008

Conditions
Healthy
Interventions
DRUG

OROS methylphenidate hydrochloride

Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of OROS MPH will be 36 mg which will be supplied as one 36 mg capsules. Study treatments will be administered with water following an overnight fast of at least 8 hours.

DRUG

methylphenidate hydrochloride

Subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4 at each of the four treatment days in a crossover fashion, so that each subject will have received doses of each combination of treatments during the study. Each dose of IR MPH will be 20 mg which will be supplied as one 20 mg capsule. Study treatments will be administered with water following an overnight fast of at least 8 hours.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT00302393 - Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults | Biotech Hunter | Biotech Hunter