NCT03161509

Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Detailed description

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects. Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Conditions

• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DRUG	Paracetamol	single dose of 1 gr paracetamol
DRUG	Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)	Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2017-05-19
• Last updated: 2021-09-24

Locations

1 site across 1 country: Israel