NCT01130922

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastric Bypass
• Body Weight

Interventions

Type	Name	Description
DRUG	moxifloxacin per IV	intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)
DRUG	moxifloxacin per os	oral administration of 400 mg moxifloxacin in a single dose

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-05-26
• Last updated: 2011-04-18

Locations

1 site across 1 country: Belgium