De studie wordt uitgevoerd in gezonde vrijwilligers met als doel te onderzoeken of er een meetbare concentratie piracetam in de urine ontstaat na subtherapeutisch dosering piracetam. Er wordt dus geen effect op een aandoening onderzocht. n.v.t. (zie uitleg onder vraag C21)
Conditions
Interventions
All included participants will administer the investigational product once
weekly according to the following scheme:
Week 1 (day 1): 7.5 mg (6 tablets)
Week 2 (day 1): 5 mg (4 tablets)
Week 3 (day 1
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be considered eligible to participate in this study, all of the following requirements must be met: 1. Age >= 18 years; 2. Able and willing to give written informed consent; 3. Able and willing to undergo urine sampling for analysis; 4. Able and willing to digest multiple tablets at day one of each study week (6 tablets of 1.25 mg in week 1; 4 tablets of 1.25 mg in week 2; 2 tablets of 1.25 mg in week 3 and 1 tablet of 1.25 mg in week 4)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Current prescribed treatment with piracetam; 2. Pregnant or breastfeeding; 3. Criteria regarding the following contra-indications for piracetam: - Cerebral haemorrhage; - Huntington's chorea; - Hypersensitivity to pyrrolide derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verifying the detectability of piracetam in urine after administration of the planned doses using an in-house High-Performance Liquid Chromotography-tandem Mass Spectrometry (HPLC-MS/MS) assay | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the piracetam urine concentrations after nonadherence of two days | — |
Countries
Netherlands
Outcome results
None listed