Pharmacokinetics of Paracetamol before and after Roux-en-Y gastric bypass

Phase 4

Withdrawn

• Conditions: Roux-en-Y gastric bypass; gastric bypass; 10017998

• Registration Number: NL-OMON48508
• Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

- * 18 years old
- on the waiting list of getting a Roux-en-Y gastric bypass
- mentally competent
- provided informed consent

Exclusion Criteria

- patient undergoing different types of bariatric surgery, such as gastric band, gastric sleeve, mini gastric bypass or revision RYGB
- patient who previously underwent a gastric surgery, such as gastric band, RYGB or gastric sleeve
- taken paracetamol < 24 h before blood sampling at t=0
- allergy or intolerance for paracetamol
- not being able to take paracetamol orally
- to vomit after intake of paracetamol
- to be pregnant

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is the pharmacokinetics (absorption constant, clearance,<br /><br>distribution volume, peak concentration, time at which peak<br /><br>concentration was observed, area under the curve) of paracetamol and its<br /><br>metabolites (paracetamol glucuronide, paracetmol sulfate, paracetamol<br /><br>mercatopurate and paracetamol cysteine) after a single oral dose of 1000 mg<br /><br>paracetamol before and after RYGB.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary end points are ASAT, ALAT, *-GT and bilirubin values at T=0 min and<br /><br>T=6 h.</p><br>