Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-01-01

Brief Summary

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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.

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Detailed Description

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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

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Bariatric Surgery Candidate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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paracetamol

10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

single dose of 1 gr paracetamol

antiepileptic drug

Up to 10 participants in each drug (up to 4 medications, total of up to 40 participants) will undergo measurement of levels of their chronic medication after a dose before and after sleeve gastrectomy

Group Type EXPERIMENTAL

Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)

Intervention Type DRUG

Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose

Interventions

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Paracetamol

single dose of 1 gr paracetamol

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Antiepileptic

Eligibility Criteria

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Inclusion Criteria

1. BMI over 30 and eligible for sleeve gastrectomy
2. Mentally capable for consent
3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

Exclusion Criteria

1. Gastrointestinal illness impairing absorption
2. renal failure (glomerular filtration rate\<45)
3. liver cirrhosis
4. heart failure (New York Heart Association class III or IV)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes