Effect of Stomach Reduction Surgery on the Parameters of Amoxicillin

• Status: Completed
• Trial end date: 2017-04-03
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
• Collaborator: University of Campinas, Brazil
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.