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Drug Metabolism, Poor, CYP2D6-RELATED | Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Drug Metabolism, Poor, CYP2D6-RELATED research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Drug Metabolism, Poor, CYP2D6-RELATED

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DiphenhydramineDiphenhydramine 50 mg oral once

Drug:Metoclopramide10 mg i.v. metoclopramide once

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MetoclopramideMetoclopramide treatment

DiphenhydramineDiphenhydramine treatment

Study Status

Terminated

Start Date: July 2009

Completed Date: June 2015

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Area under curve of metoclopramide (MCP)

Secondary Outcome: Cmax of metoclopramide

Study sponsors, principal investigator, and references

Principal Investigator: Matthias Schwab, MD

Lead Sponsor: Matthias Schwab

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01289938

Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim Biophys Acta. 2007 Mar;1770(3):489-94. Epub 2006 Oct 4. Review.

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