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Effect of Stomach Reduction Surgery on the Parameters of Amoxicillin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588273
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
marina becker sales rocha, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

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).


Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Drug: Amoxil 500 MG Oral Capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Bariatric Surgery on the Pharmacokinetics Parameters of Amoxicillin
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : April 3, 2017
Actual Study Completion Date : April 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Amoxil 500 mg Oral Capsule Time 0
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



Primary Outcome Measures :
  1. Change on the plasma concentration of amoxicillin [ Time Frame: Before and 2 months after bariatric surgery. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588273


Locations
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Brazil
Nucleo de Pesquisa e Desenvolvimento da Universidade Federal do Ceara
Fortaleza, CE, Brazil, 60430-275
Sponsors and Collaborators
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
University of Campinas, Brazil
Investigators
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Principal Investigator: Maria Elisabete A De Moraes, MD, PhD Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceara (UFC)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: marina becker sales rocha, Principal investigator, BSNut, PhD, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
ClinicalTrials.gov Identifier: NCT03588273    
Other Study ID Numbers: Projeto Cirurgia Bariátrica
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by marina becker sales rocha, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara:
Bariatric surgery
Pharmacokinetics
Amoxicillin
Obesity
Additional relevant MeSH terms:
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Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents