Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289938

Acronym

MalD

Enrollment

Registered

2011-02-04

Start date

2009-07-31

Completion date

2015-06-30

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Metabolism, Poor, CYP2D6-RELATED

Keywords

pharmacokinetic, pharmacogenetic, Metoclopramide, Diphenhydramine, CYP2D6 polymorphisms

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

Interventions

DRUGDiphenhydramine

Diphenhydramine 50 mg oral once

DRUGMetoclopramide

10 mg i.v. metoclopramide once

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026