A Double-blind Randomized, Placebo-controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults
|ClinicalTrials.gov Identifier: NCT00302354|
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : July 12, 2011
This is a double-blind, placebo-controlled study, three-period crossover study to examine the likeability of a single dose of OROS MPH (CONCERTAÒ 90mg) and a single dose of Long-acting MPH (RITALIN LAÒ 90mg). Hypotheses are as follows:
Hypothesis 1: OROS-MPH (CONCERTAÒ) will be later than SODOS-MPH (RITALIN LAÒ) in its Tmax (time to Cmax).
Hypothesis 2: The subjective feelings of detection and likeability would be greater for SODOS-MPH (RITALIN LAÒ) than for an equivalent total dose of OROS-MPH (CONCERTAÒ).
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: OROS methylphenidate HCl Drug: SODAS methylphenidate HCl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Double-blind Randomized, Placebo-controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults|
|Study Start Date :||December 2004|
|Primary Completion Date :||September 2005|
|Study Completion Date :||September 2005|
- Objective measures provided by hourly d and l ritalinic acid and methylphenidate levels from pre-dose and hours 1,2,3,4,5,6,7,8,10, and 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302354
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Thomas Spencer, MD||Massachusetts General Hospital|