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Sponsors and Collaborators: |
Massachusetts General Hospital McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00302354 |
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 | Intervention | Phase |
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Healthy Volunteers |
Drug: OROS methylphenidate HCl Drug: SODAS methylphenidate HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | September 2005 |
Our recent work has suggested that the potential euphoriant risk associated with MPH may be moderated by the oral delivery system in which a longer delivery system may be safer than the immediate release one. OROS-MPH’s pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. Another new long-acting MPH formulation is the spheroidal oral drug absorption system (SODAS). SODAS-MPH consists of capsules with two types of beads in a 1 to 1 ratio. Evaluating whether different long acting formulations of MPH will differ in their rate of onset of MPH action (plasma level) is of high clinical, scientific and public health relevance. Since the rate of delivery of MPH is a key factor previously associated with detection and likeability of MPH.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant abnormal baseline laboratory values which include the following:
United States, Massachusetts | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Thomas Spencer, MD | Massachusetts General Hospital |
Study ID Numbers: | 2004-P-002212 |
Study First Received: | March 13, 2006 |
Last Updated: | March 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00302354 |
Health Authority: | United States: Food and Drug Administration |
Dopamine Methylphenidate Healthy |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |