NCT01845194

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

Open Label Repeated Dose Study for the Evaluation of Heritability of and Genetic Influences on Drug Pharmacokinetics (TWINS II)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-05-03
• Last updated: 2014-04-21

Locations

1 site across 1 country: Germany