Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

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

Official Title
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Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Conditions
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Drug Metabolism, Poor, CYP2D6-RELATED

Intervention / Treatment
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* Drug: Diphenhydramine
* Drug: Metoclopramide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metoclopramide<br>Metoclopramide treatment | Drug: Metoclopramide<br>* 10 mg i.v. metoclopramide once<br>* Other names: MCP;|
| Active Comparator: Diphenhydramine<br>Diphenhydramine treatment | Drug: Diphenhydramine<br>* Diphenhydramine 50 mg oral once<br>* Other names: DPH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve of metoclopramide (MCP) | 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 | 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours | 
| Area under curve of diphenhydramine(DPH) | 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 | 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of metoclopramide | 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 | 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours | 
| Tmax of metoclopramide | 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 | 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours | 
| Cmax of diphenhydramine | 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 | 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours | 
| Tmax of diphenhydramine | 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 | 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetic, pharmacogenetic, Metoclopramide, Diphenhydramine, CYP2D6 polymorphisms