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ACTIVE NOT RECRUITING
NCT05621174
NA

The Difference in the Mechanism of Action Between Two Brands of Dexamfetamine in Adults With ADHD

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare in the pk/pd profiles of magisterial dexamfetamine and Tentin in adults with Attention Deficit Hyperactivity Disorder (ADHD). The main question\[s\] it aims to answer are: Q1: is there a difference between pk/pd profiles of the two forms of dexamfetamine? Q2: how does the pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD? Participants will: * take the Quantified behavior Test for analysis of objective effects. * undergo blood sampling for analysis of the plasma concentration of dexamphetamine. * undergo blood pressure and heart rate measurements. * fill out 4 types of questionnaires. Researchers will compare the outcomes between magisterial dexamphetamine and Tentin use in a crossover setting.

Official title: The Difference in Pharmacodynamic and Pharmacokinetic Profiles Between Tentin and Magisterial Dexamfetamine in Adults With Attention Deficit Hyperactivity Disorder, a Double Blinded Randomised Crossover-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2023-04-14

Completion Date

2025-12-31

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

DRUG

Dexamfetamine

Magisterial Dexamfetamine

DRUG

Dexamfetamine

Tentin

Locations (1)

Glenn Dumont

Amsterdam, North Holland, Netherlands