Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine (MalD)

This study is currently recruiting participants.
Verified January 2013 by University Hospital Tuebingen
Sponsor:
Information provided by (Responsible Party):
Matthias Schwab, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01289938
First received: February 2, 2011
Last updated: January 31, 2013
Last verified: January 2013

February 2, 2011
January 31, 2013
July 2009
December 2013   (final data collection date for primary outcome measure)
  • Area under curve of metoclopramide (MCP) [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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) [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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

Same as current
Complete list of historical versions of study NCT01289938 on ClinicalTrials.gov Archive Site
  • Cmax of metoclopramide [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72 hours ] [ Designated as safety issue: No ]

    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

Same as current
Not Provided
Not Provided
 
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Drug Metabolism, Poor, CYP2D6-RELATED
  • Drug: Diphenhydramine
    Diphenhydramine 50 mg oral once
    Other Name: DPH
  • Drug: Metoclopramide
    10 mg i.v. metoclopramide once
    Other Name: MCP
  • Active Comparator: Metoclopramide
    Metoclopramide treatment
    Intervention: Drug: Metoclopramide
  • Active Comparator: Diphenhydramine
    Diphenhydramine treatment
    Intervention: Drug: Diphenhydramine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Not Provided
Germany
 
NCT01289938
IKP231, 2008-003778-16
No
Matthias Schwab, University Hospital Tuebingen
Matthias Schwab
Not Provided
Principal Investigator: Matthias Schwab, MD UKT
University Hospital Tuebingen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP