NCT03575312

Pharmacokinetics of Enrofloxacin in Plasma and Urine

Pharmacokinetic Study to Assess and Compare the Pharmacokinetics of Enrofloxacin After Dermal, Inhaled, and Oral Dosing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Antibiotics like enrofloxacin are widely used in animal farming to treat and prevent bacterial infections. A previous study in poultry farms has shown that yardmen show significant concentrations of administered antibiotics in their urine. It is currently unclear how poultry yardmen are exposed to the administered antibiotics. The objective of this exemplarily study is to obtain information on the pharmacokinetics of the different uptake routes (oral, inhaled or dermal).

Detailed description

Study subjects will be exposed to enrofloxacin at a concentration level representative for occupational exposure of yardmen at poultry farms. As three uptake-routes, oral, inhalation and dermal, are conceivable all three cases will be investigated. After administration blood and urine samples will be analysed for enrofloxacin and its main metabolite ciprofloxacin at several time points. The objective of this exemplarily study is to obtain information on the pharmacokinetics of the different uptake routes. If different exposure routes are characterized by different pharmacokinetics, such studies can be used to obtain a better understanding of general routes of exposure in occupational environments. On the basis of the results mitigation strategies can be developed, reducing the risk of exposure.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Enrofloxacin	dermal application, inhalation rsp. oral administration of Enrofloxacin

Timeline

• Start date: 2018-04-27
• Primary completion: 2018-06-04
• Completion: 2018-08-30
• First posted: 2018-07-02
• Last updated: 2018-12-12

Locations

1 site across 1 country: Germany