Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass

Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130922

Acronym

DRUG10_MOXI

Enrollment

Registered

2010-05-26

Start date

2010-03-31

Completion date

2010-06-30

Last updated

2011-04-18

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

Conditions

Body Weight, Gastric Bypass

Keywords

Roux-and-Y gastric bypass surgery, stable body weight

Brief summary

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.

Interventions

DRUGmoxifloxacin per IV

intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)

DRUGmoxifloxacin per os

oral administration of 400 mg moxifloxacin in a single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

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 \< 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

Design outcomes

Primary

Measure	Time frame
To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass	72 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026