First Time in Man Study of Finafloxacin Hydrochloride
Completed
MerLion Pharmaceuticals GmbH
Phase 1
2007-08-01
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.
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
Completed
MerLion Pharmaceuticals GmbH
Phase 2
2008-09-01
The primary objective of this study is to compare the H. pylori eradication rates with
Finafloxacin in combination with Amoxicillin or Esomeprazole.
The secondary objective is to evaluate and compare the safety and tolerability of multiple
oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole.
Effect of Age and Gender on the PK and Tolerability of Finafloxacin
Completed
MerLion Pharmaceuticals GmbH
Phase 1
2010-02-01
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.
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