At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled, Crossover Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
In Brief
A Phase 4 clinical trial evaluating OROS-Methylphenidate, Immediate Release Methylphenidate, and 1 other intervention for Healthy. Completed, enrolled 44 participants across 1 site.
Detailed Summary
This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows: * Hypothesis 1: the subjective feelings of detection and likeability will be greater for periods of IR-MPH administration than after OROS-MPH administration irregardless of sequence; * Hypothesis 2: the greater ratings of feelings of detection and likeability will be associated with the periods of most rapid change in plasma d-MPH and not with the magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in which they coincide), and * Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions in which IR-MPH is the second condition.
Study Details
Timeline
Interventions
Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules
Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules
Placebo will be administered during the first part of the day, and again during the second part of the day.