Overview

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

Status:
Completed

Trial end date:
2008-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

University Hospital Freiburg

Collaborator:

Novartis

Treatments:

Central Nervous System Stimulants
Methylphenidate