Effect of Stomach Reduction Surgery on the Parameters of Amoxicillin

NCT03588273 | Completed

• 1 other identifier: Projeto Cirurgia Bariátrica
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin. Methods: This study was performed as a randomized, open-label, single-dose clinical trial, with two periods of treatment, in which obese subjects (n=8) received amoxicillin 500 mg capsule orally before and 2 months after the Roux-en-Y gastric bypass surgery. The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry (LC-MS/MS).

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgery; Pharmacokinetics; Amoxicillin; Obesity

Outcome Measures

Primary Outcomes (1)

• Change on the plasma concentration of amoxicillin

  Blood samples (6 mL) for determination of plasma concentration of amoxicillin were collected via a venous catheter into heparinized tubes at pre-dose (0 h), 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h post-dose.

  Before and 2 months after bariatric surgery.

Study Arms (1)

Amoxil 500 mg Oral Capsule Time 0

OTHER

In each period (before the surgery and 2 months after the bariatric surgery) the obese volunteers received a single oral dose of amoxicillin 500 mg capsule (Amoxil®, GlaxoSmithKline Brazil Ltda.) with 200 mL water after an overnight fast (approximately 8 h).

Drug: Amoxil 500 MG Oral Capsule

Interventions

Amoxil 500 MG Oral Capsule DRUG

Amoxil 500 mg Oral Capsule Time 0

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers of both sexes;
• Aged between 18 and 60 years old;
• Indication of bariatric surgery based on the criteria established by the Federal Medical Council (2015);
• Volunteers operated using the RYGB surgery technique.

You may not qualify if:

• Hypersensitivity to amoxicillin or to chemically related compounds;
• History of serious adverse reactions;
• Hospitalization for any reason during the eight weeks before the beginning of the study;
• Blood donation or other blood loss of more than 450 mL within three months prior to individual enrolment of the subject;
• Surgery of digestive tract prior to bariatric surgery;
• History or presence of liver, kidney, gastrointestinal or serious heart disease or other conditions that could interfere with the absorption, distribution, excretion or metabolism of the drug;
• Continuous use of the studied medication;
• Pregnancy and/or breastfeeding in the case of female volunteers.

Sponsors & Collaborators

• Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara

Fortaleza, Ceará, 60430-275, Brazil

Location

Related Publications (1)

• Rocha MBS, De Nucci G, Lemos FN, de Albuquerque Lima Babadopulos RF, Rohleder AVP, Fechine FV, Antunes NJ, Mendes GD, do Nascimento DF, de Moraes MO, de Moraes MEA. Impact of Bariatric Surgery on the Pharmacokinetics Parameters of Amoxicillin. Obes Surg. 2019 Mar;29(3):917-927. doi: 10.1007/s11695-018-3591-3.

  PMID: 30415354 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Maria Elisabete A De Moraes, MD, PhD

  Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, BSNut, PhD

Model Details: Monocentric, open-label, single-dose study with two treatment periods - before the surgery (Time 0 - T0) and 2 months after the bariatric surgery (Time 2 - T2).

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 17, 2018
• Study Start: June 24, 2016
• Primary Completion: April 3, 2017
• Study Completion: April 3, 2017
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

BR (1)