Pharmacokinetic evaluation of moxifloxacin administered intravenously and orally in healthy volunteers who have had a gastric bypass.

niversity Ghent0 个研究点开始时间: 2010年3月1日最近更新: 2016年8月16日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

发起方

niversity Ghent