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Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

NCT02135263 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-07-30

No results posted yet for this study

Summary

The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1 dependent drugs, enalapril and methylphenidate.

Conditions

  • Carboxylesterase 1 (CES1) Genotype
  • CES1 Activity

Interventions

DRUG

Methylphenidate

10 mg as a single dose followed by blood samples for the next 33 hours

DRUG

Enalapril

10 mg as a single dose followed by blood samples for the next 72 hours

Sponsors & Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

    collaborator OTHER_GOV

  • Mental Health Centre Sct. Hans (Denmark)

    collaborator UNKNOWN

  • University of Copenhagen

    collaborator OTHER

  • The Leiden Academic Center for Drug Research (LACDR)

    collaborator UNKNOWN

  • Duke University

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Gesche Jürgens, M.D. · Department of Clinical Pharmacology, Bispebjerg University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135263 on ClinicalTrials.gov