FindTrial
Sign In

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

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

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48508
Enrollment
28
Registered
2019-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Roux-en-Y gastric bypass

Interventions

paracetamol
pharmacokinetics
Roux-en-Y gastric bypass

Sponsors

Albert Schweitzer Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secundary end points are ASAT, ALAT, *-GT and bilirubin values at T=0 min and T=6 h.—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)