drugset / Trial / NCT02514941

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

NCT02514941

Phase 1 Completed 12 enrolled University Medicine Greifswald
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2007-06
Primary completion
2010-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 200 mg Oral
Subject Amoxicillin Other / unclassified 250 mg Oral
Subject Talinolol Small molecule 50 mg Oral

Indications