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Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics

NCT01845194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2014-04-21

No results posted yet for this study

Summary

This human pharmacokinetic study investigates, whether processes of drug metabolism and transport are determined by genetic or hereditary factors. Therefore, approved drugs are applied to twins and metabolism and transport processes are investigated.

Conditions

  • Drug Biotransformation
  • Membrane Transport

Interventions

DRUG

Codeine

Treatment period 2: 5 mg Codeine once

DRUG

Midazolam

Treatment period 1: 0.2 mg Midazolam 3x Treatment period 2: 1 mg Midazolam once

DRUG

Pravastatin

Treatment period 2: 5 mg Pravastatin once

DRUG

Torsemide

Treatment period 1: 2.5 mg Torsemide 3x Treatment period 2: 0.25 mg Torsemide once

DRUG

Talinolol

Treatment period 1: 50 mg Talinolol 3x Treatment period 2: 2.5 mg Talinolol once

DRUG

Caffeine

Treatment period 1: 50 mg Caffeine 3x

DRUG

Metoprolol

Treatment period 1: 5 mg Metoprolol 3x

Sponsors & Collaborators

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    lead OTHER

Principal Investigators

  • Jürgen Brockmöller, Prof. · Dept. of Clinical Pharmacology, Georg-August-University of Goettingen, Robert-Koch-Str. 40, 37075 Goettingen, Germany

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Germany

Study Locations

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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 NCT01845194 on ClinicalTrials.gov