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Pharmacokinetics of Two Extended-Release Formulations of Methylphenidate in Children With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00772161 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-01-21

No results posted yet for this study

Summary

This study is designed to provide pharmacokinetic data for the assessment of bioequivalence of Ritalin LA formulation compared to Medikinet ret. concerning plasma levels and efficacy measures.

The primary objective of the study is to determine the pharmacokinetic parameters and bioequivalence of Ritalin LA compared to Medikinet retard, both given as oral o.d. doses of 20 mg over 7 days in children with ADHD. The secondary objectives are to assess the efficacy, safety and tolerability of Ritalin LA and Medikinet retard and the association of these parameters with plasma levels.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Methylphenidate

Comparison of two extended-release formulations of 20mg Methylphenidate in a cross-over design.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Christian Fleischhaker, MD · Universitätsklinikum Freiburg

  • Eberhard Schulz, Prof. Dr. · Universitätsklinikum Freiburg

  • Klaus Hennighausen, MD · University Hospital Freiburg, Dep. for Child & Adoslecent Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00772161 on ClinicalTrials.gov