Phase I pharmacokinetic interaction study of dextromethorphan with supplementation of grape seed extract

Completed

• Conditions: Not applicable.; gezonde vrijwilligers

• Registration Number: NL-OMON37784
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dextromethorphan (DM) to dextrorphan (DX) metabolic ratio (MR) in urine<br /><br>collected up to 8 h after dextromethorphan administration.<br /><br>MR = (0-8 h urinary output of DM) / (0-8 h urinary output of DX). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Incidence of dextromethorphan-related adverse events. </p><br>