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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018628-14-BE

Enrollment

Registered

2010-03-01

Start date

2010-03-11

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers who have had a gastric bypass at least 6 months ago

Interventions

Trade Name: Avelox I.V. Product Name: Moxifloxacine IV Pharmaceutical Form: Solution for infusion INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE CAS Number: 186826868 Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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 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

Design outcomes

Primary

Measure	Time frame
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 ;Secondary Objective: Determination of the absolute bioavailability of moxifloxacin after oral administration in healthy volunteers who have had a gastric bypass ;Primary end point(s): Plasma concentrations at different timepoints, until 72 hours postdose	—

Measure

Time frame

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 ;Secondary Objective: Determination of the absolute bioavailability of moxifloxacin after oral administration in healthy volunteers who have had a gastric bypass ;Primary end point(s): Plasma concentrations at different timepoints, until 72 hours postdose

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026