Impact of Bariatric Surgery on the Pharmacokinetics Parameters of Amoxicillin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change on the plasma concentration of amoxicillin
研究概览
简要总结
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).
详细描述
Study population
Eight obese volunteers of both sexes, aged between 18 and 60 years old, were selected from the obesity program of Hospital General Dr. César Cals with indication of bariatric surgery based on the criteria established by the Federal Medical Council (2015) and who were operated using the RYGB surgery technique.
All subjects signed the informed consent form. The study was approved by the institutional review board (IRB) of the Federal University of Ceará, accredited by the National Commission for Research Ethics - National Health Council, Ministry of Health and the Scientific Committee of the Hospital General Dr. César Cals. The study was performed according to the ethical principles of the Declaration of Helsinki as revised in 2013 and Good Clinical Practice Guidelines.
Study design and pharmacokinetic sampling
This study was performed as a monocentric, open-label, randomized, single-dose study with two treatment periods - before the surgery (Time 0 - T0) and 2 months after the bariatric surgery (Time 2 - T2). In each period, 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). The subjects remained fasted for up to 3 h after taking the medication. Water and food restriction was held up to 3 h after the intake of the formulation. Standard meals were offered to all subjects. The volunteers who needed to use any medication (antihypertensive, antidiabetic and others) were instructed to use it 3 h after the intake 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. The plasma samples for chromatographic analysis were obtained by centrifugation (2000 g x 12 min at 4 ºC) of the blood samples. Plasma samples were stored at -20 °C until the analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Amoxil 500 MG Oral Capsule (Drug)
结局指标
主要结局
Change on the plasma concentration of amoxicillin
时间窗: 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.
次要结局
未报告次要终点
研究者
marina becker sales rocha
Principal investigator, BSNut, PhD
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara