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Effect of Stomach Reduction Surgery on the Parameters of Amoxicillin

NCT03588273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-07-18

No results posted yet for this study

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

Interventions

DRUG

Amoxil 500 MG Oral Capsule

Sponsors & Collaborators

  • University of Campinas, Brazil

    collaborator OTHER

  • Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

    lead OTHER

Principal Investigators

  • Maria Elisabete A De Moraes, MD, PhD · Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-24
Primary Completion
2017-04-03
Completion
2017-04-03

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588273 on ClinicalTrials.gov