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

Matthias Schwab

Status and phase: Terminated; Phase 1

Conditions: Drug Metabolism, Poor, CYP2D6-RELATED

Treatments: Drug: Diphenhydramine; Drug: Metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT01289938

2008-003778-16 (EudraCT Number)

IKP231

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Metoclopramide

Active Comparator group

Description:

Metoclopramide treatment

Treatment:

Drug: Metoclopramide

Diphenhydramine

Active Comparator group

Description:

Diphenhydramine treatment

Treatment:

Drug: Diphenhydramine