Pharmacokinetic evaluation of moxifloxacin administered intravenously and orally in healthy volunteers who have had a gastric bypass.
- Conditions
- Healthy volunteers who have had a gastric bypass at least 6 months ago
- Registration Number
- EUCTR2010-018628-14-BE
- Lead Sponsor
- niversity Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• 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
• Epilepsy
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the moxifloxacin plasma levels and the variability in healthy volunteers who have had a gastric bypass, after intravenous and oral administration of 400mg moxifloxacin<br>;Secondary Objective: Determination of the absolute bioavailability of moxifloxacin after oral administration in healthy volunteers who have had a gastric bypass<br>;Primary end point(s): Plasma concentrations at different timepoints, until 72 hours postdose
- Secondary Outcome Measures
Name Time Method