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

NCT01904162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-13

No results posted yet for this study

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

DRUG

400 mg finafloxacin (2 x 200 mg tablets)

Sponsors & Collaborators

  • MerLion Pharmaceuticals GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01904162 on ClinicalTrials.gov