Trials / Completed
CompletedNCT02768441
Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots
Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamphetamine | Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2016-05-11
- Last updated
- 2017-06-02
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02768441. Inclusion in this directory is not an endorsement.