Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cytokines Polymorphisms and Acetaminophen Toxicity

NCT00166608

Drug Toxicity

COMPLETED

Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

NCT05097716

Healthy Volunteers

COMPLETED PHASE1

Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

NCT03617471

Pain

COMPLETED NA

Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline

NCT00779259

Pharmacokinetics

COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment

NCT04859426

Hepatic Impairment

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

normal weight patients

normal weight patients receiving acetaminophen 2 g instead of 1 g

Group Type EXPERIMENTAL

acetaminophen 2 g

Intervention Type DRUG

mobidly obese patients

morbidly obese patients receiving acetaminophen 2 g instead of 1 g

Group Type EXPERIMENTAL

acetaminophen 2 g

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acetaminophen 2 g

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI \> 40 kg/m2 undergoing bariatric surgery.
* Patients between 18 - 60 years old
* ASA physical classification of II or III
* All racial and ethnic groups will be included

* BMI between 18 and 25 kg/m2 undergoing general surgery
* Patients between 18 - 60 years old
* ASA (American Society of Anesthesiology) physical classification of I, II or III
* All racial and ethnic groups will be included

Exclusion Criteria

* Renal insufficiency
* Liver disease
* Patients with Gilbert-Meulengracht syndrome
* Chronic alcohol intake or use of alcohol within last 72 hours
* Pregnancy or breastfeeding
* Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
* Diabetes mellitus type II patients
* Smoking
* Acetaminophen intake before the study (24 hours before study)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes