NCT01904162

Effect of Age and Gender on the PK and Tolerability of Finafloxacin

Determination of the Effect of Age and Gender on the Pharmacokinetics and Tolerability of a Single Dose of Finafloxacin-HCL in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: MerLion Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Previous clinical studies have indicated that finafloxacin is well-tolerated with few treatment-related adverse events. As a part of the clinical development of finafloxacin, other PK studies are required to determine the effect of other variables on the PK profile of finafloxacin. This study aims to determine the effect of age and gender on the pharmacokinetic profile of finafloxacin.

Conditions

• Pharmacokinetic and Tolerability of Finafloxacin

Interventions

Type	Name	Description
DRUG	400 mg finafloxacin (2 x 200 mg tablets)

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2013-07-22
• Last updated: 2024-03-13

Locations

1 site across 1 country: United States