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OpenTrials
Completed

NCT Number: NCT02768441

Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.

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Key information

Conditions

Cocaine Addiction Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

AMC

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have completed at least 80% of the previous study (CATCH)
  • Be able and willing to participate in the study and assessments
  • Have provided written informed consent.

Exclusion criteria

  • Any intake of dexamphetamine 7 days or less before the start of the proposed study;
  • Contraindications for dexamphetamine
  • (desired) pregnancy or continued lactation
  • Insufficient command of the Dutch language
  • Current participation in another trial

Treatment and study plan

Dexamphetamine

Drug

Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days

Primary outcomes

  1. Area under the Curve (AUC) of dexamphetamine

    Time frame: Determined on the 5 day bloodsamples taken

  2. Maximum plasma concentration (Cmax) of dexamphetamine

    Time frame: Determined on the 5 day bloodsamples taken

  3. Half life (T 1/2) of dexamphetamine

    Time frame: Determined on the 5 day bloodsamples taken

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2016
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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