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First Time in Man Study of Finafloxacin Hydrochloride

NCT00483158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2008-07-29

No results posted yet for this study

Summary

The purpose of this study is to study the safety of single doses and multiple doses of Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride will be measured in the subjects blood and urine. One part of the study will assess if Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part of the study will assess the activity of the drug in urine.

Conditions

Interventions

DRUG

Finafloxacin hydrochloride

Tablets, oral single dose and multiple dose once daily for 7d

Sponsors & Collaborators

  • MerLion Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Seiberling, MD · SWISS PHARMA CONTRACT LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00483158 on ClinicalTrials.gov