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

NCT05621174 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Dexamfetamine

Magisterial Dexamfetamine

DRUG

Dexamfetamine

Tentin

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Glenn JH Dumont, PhD · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-14
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Netherlands

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 NCT05621174 on ClinicalTrials.gov