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A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults

NCT00301639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-07-12

No results posted yet for this study

Summary

The specific aim of this study is to document the pharmacokinetics of dopamine transporter DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of Metadate CD at 10 hours after administration.

Conditions

  • Healthy Volunteers

Interventions

DRUG

OROS methylphenidate hydrochloride

DRUG

methylphenidate hydrochloride

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Thomas Spencer, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00301639 on ClinicalTrials.gov