gezonde vrijwilligers Not applicable.
Conditions
Interventions
- Administration of 15 mL 2 mg/mL dextromethorfan cough syrup on day 1 and 10.
- Ingestion of 3 times daily 1 capsule of grapeseed extract during 2 days,
followed by 1 ingestion in the morning of th
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteer; 2. Age 18 years or older; 3. Able and willing to give written informed consent; 4. Able and willing to undergo blood sampling for CYP2D6 genotyping; 5. Able and willing to swallow and retain oral medication; 6. Able and willing to collect urine for pharmacokinetic analysis; 7. Willing to comply to the protocol and to follow dietary restrictions.
Exclusion criteria
Exclusion criteria: 1. Concomitant medication known to be moderate or strong inhibitors of CYP2D6 for at least two weeks prior to study start, including bupropion, cinacalcet, fluoxetine, paroxetine, quinidine, duloxetine, sertraline, terbinafine, amiodarone and cimetidine. 2. Concomitant medication known to be moderate or strong inducers of inhibitors of CYP3A for at least two weeks prior to study start, including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, saquinavir, telithromycine, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem, rifampicin, St. John*s wort and carbamazepine. 3. Any treatment with investigational drugs within two weeks prior to receiving the first dose of investigational treatment; 4. Use of alcohol (max. 2 units per day allowed), grapefruit or grapefruit juice for at least two weeks prior to study start until handing in collected urine on day 10. 5. Contra-indications for dextromethorphan use (e.g. treatment with MAO inhibitors, severely impaired liver function).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dextromethorphan (DM) to dextrorphan (DX) metabolic ratio (MR) in urine collected up to 8 h after dextromethorphan administration. MR = (0-8 h urinary output of DM) / (0-8 h urinary output of DX). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of dextromethorphan-related adverse events. | — |
Countries
Netherlands
Outcome results
None listed