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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medicine Greifswald
• Treatments: Acetaminophen; Amoxicillin; Talinolol

Criteria

Inclusion Criteria:

• patients who are subjected to proximal stomach-bypass surgery by entire medical reasons independent of the objectives of this study

• age: over 18 years

• sex: male and female

• ethnic origin: Caucasian

• written informed consent

Exclusion Criteria:

• abnormal low hemoglobin values (< 6.5 mmol/l [female]; < 7.6 mmol/l [male])

• obstructive lung disease (e.g. bronchial asthma)

• acute myocardial infarction

• peripheral arterial circulatory disturbance

• any disturbance of impulse formation and conduction

• bradycardia (< 50 beats/min)

• hypotension (systolic pressure < 90 mmHg)

• phaeochromocytoma

• subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

• blood donation or other blood loss of more than 400 ml within the last 3 months prior to the start of the study

• participation in a clinical trial during the last 3 months prior to the start of the study

• less than 14 days after last acute disease

• treatment with paracetamol, amoxicillin or talinolol 7 days before the study

• repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence drug biotransformation and drug transport

• intake of grapefruit containing food or beverages within 7 days prior to administration

• known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparation, also against penicillin

• subjects with severe allergies or multiple drug allergies