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Bioavailability of Paracetamol, Amoxicillin and Talinolol Before, Immediately and One Year After Gastric Bypass Operation

NCT02514941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-08-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate pharmacokinetics of paracetamol, amoxicillin and talinolol in morbid adipose subjects before as well as shortly after and about one year after proximal Roux-en-Y Gastric Bypass (RYGB) and to measure messenger ribonucleic acid (mRNA) expression and protein content of duodenal and/or jejunal drug metabolizing enzymes (eg. cytochrome P450 isoenzyme 3A4 (CYP3A4), uridine diphosphoglucuronosyltransferase (UGTs)) and drug transport proteins (e.g. P-glycoprotein, MRP2, OATPB, PEPT) before and during the operation and about one year after proximal RYGB.

Conditions

  • Morbid Obesity

Interventions

DRUG

paracetamol

Administration of 5 ml Paracetamol Saft Hexal (= 200 mg paracetamol)

DRUG

amoxicillin

Administration of 5 ml Amoxypen® 250 mg Saft (= 250 mg amoxicillin)

DRUG

talinolol

Administration of 1 tablet Cordanum® 50 (= 50 mg talinolol) dissolved with 40 ml tap water

PROCEDURE

gastroduodenoscopy with biopsy

Gastroduodenoscopy with biopsy of the lower duodenum before the first pharmacokinetic study period

PROCEDURE

gastrojejunoscopy with biopsy

Gastrojejunoscopy with biopsy of the jejunum about one year after proximal Roux-en-Y gastric bypass

PROCEDURE

proximal Roux-en-Y gastric bypass

sampling of a tissue specimen from the jejunum during the operation

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Werner Siegmund, Prof · Department of Clinical Pharmacology

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT02514941 on ClinicalTrials.gov