Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Information source: University Hospital Tuebingen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Metabolism, Poor, CYP2D6-RELATED
Intervention: Diphenhydramine (Drug); Metoclopramide (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Matthias Schwab Official(s) and/or principal investigator(s): Matthias Schwab, MD, Principal Investigator, Affiliation: UKT
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
Clinical Details
Official title: Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Area under curve of metoclopramide (MCP)Area under curve of diphenhydramine(DPH)
Secondary outcome: Cmax of metoclopramideTmax of metoclopramide Cmax of diphenhydramine Tmax of diphenhydramine
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Abteilung Klinische Pharmakologie, UKT Tübingen, Tübingen, BW 72076, Germany
Additional Information
Related publications: 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. Schroth W, Antoniadou L, Fritz P, Schwab M, Muerdter T, Zanger UM, Simon W, Eichelbaum M, Brauch H. Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J Clin Oncol. 2007 Nov 20;25(33):5187-93.
Starting date: July 2009
Last updated: May 26, 2015
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