Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Phase 1

Terminated

• Conditions: Drug Metabolism, Poor, CYP2D6-RELATED
• Interventions: Drug: Metoclopramide; Drug: Diphenhydramine

• Registration Number: NCT01289938
• Lead Sponsor: Matthias Schwab

Brief Summary

Pharmacokinetic of Metoclopramide (MCP) in correlation to polymorphisms of CYP2D6 and Dopamine-D2-Receptor. Pharmacokinetic of Diphenhydramine (DPH) in correlation to polymorphisms of CYP2D6

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• BMI 20 - 27kg/m2
• Caucasians
• Healthy volunteers

Exclusion Criteria

• Pregnancy/lactation period
• Drug allergy
• Acute and chronic diseases
• Taking medication
• Abuse of drugs, alcohol etc.
• Smoker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metoclopramide	Metoclopramide	Metoclopramide treatment
Diphenhydramine	Diphenhydramine	Diphenhydramine treatment

Primary Outcome Measures

Name	Time	Method
Area under curve of metoclopramide (MCP)	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	Pharmacokinetic of MCP at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
Area under curve of diphenhydramine(DPH)	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	Pharmacokinetics of DPH at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application

Secondary Outcome Measures

Name	Time	Method
Tmax of diphenhydramine	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	Tmax of diphenhydramine at the following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
Cmax of metoclopramide	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	Cmax of metoclopramide at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
Tmax of metoclopramide	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	Tmax of metoclopramide at following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application
Cmax of diphenhydramine	0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours	Cmax of diphenhydramine at the following time points: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours after drug application

Trial Locations

Locations (1)

Abteilung Klinische Pharmakologie, UKT Tübingen; 🇩🇪 Tübingen, BW, Germany