drugset / Trial / NCT01130922

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

NCT01130922

Phase 4 Completed 12 enrolled University Ghent
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2010-03
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxifloxacin Small molecule 400 mg Intravenous

Indications

No indication recorded.