Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass
研究概览
简要总结
Roux-and-Y gastric bypass is one of the most common forms of bariatric surgery; due to a reduction in size of the stomach and intestine, the available surface area for the absorption of oral drugs is strongly decreased. This may lead to a reduced bioavailability resulting in a reduced efficacy of the drug. However, in literature there is no information available about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. This protocol evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who have had a gastric bypass at least 6 months ago and who now have a stable body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Healthy volunteers who have had a gastric bypass at least 6 months ago and whose body weight has not changed more than 5% during the last 3 months
- •Age between 18 and 60 years old
- •Able to give informed consent
排除标准
- •Other forms of bariatric surgery (Scopinaro and Mason/Sleeve) before gastric bypass surgery
- •Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
- •Pregnancy and lactation
- •Creatinine clearance < 80 ml/min
- •Transaminases > 2x the upper limit of normal (AST/ALT)
- •Impaired liver function (Child Pugh C)
- •Fasting glycaemia > 125mg/dl
- •Patients with a history of tendon disease/disorder (especially Achilles tendon rupture) related to quinolone treatment
- •Patients with the following heart disorders:
- •Electrolyte disturbance, particularly an uncorrected hypokalaemia
- •Clinically relevant bradycardia
- •Clinically relevant heart failure with reduced left-ventricular ejection fraction
- •Previous history of symptomatic arrhythmias
- •Congenital or documented acquired QT prolongation or concurrently use of drugs that prolong the QT interval:
- •anti-arrhythmics (Classes IA and III)
- •neuroleptics
- •tricyclic antidepressants
- •antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine)
- •some antihistamines (e.g. terfenadine, astemizole, mizolastine)
- •cisapride, intravenous vincamine, bepridil and diphemanil
- •No normal thyroid function
- •All clinically significant disorders that can interfere with the study
研究组 & 干预措施
Moxifloxacin IV
干预措施: moxifloxacin per IV (Drug)
Moxifloxacin oral
干预措施: moxifloxacin per os (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass
时间窗: 72 hours
次要结局
未报告次要终点