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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR FINAFLOXACIN

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Clinical Trials for Finafloxacin

Trial ID Title Status Sponsor Phase Summary
NCT00483158 First Time in Man Study of Finafloxacin Hydrochloride Completed MerLion Pharmaceuticals GmbH Phase 1 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.
NCT00722735 Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI) Completed MerLion Pharmaceuticals GmbH Phase 2 To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.
NCT00723502 Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Completed MerLion Pharmaceuticals GmbH Phase 2 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.
NCT01904162 Effect of Age and Gender on the PK and Tolerability of Finafloxacin Completed MerLion Pharmaceuticals GmbH Phase 1 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.
NCT01907867 Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin Completed MerLion Pharmaceuticals GmbH Phase 1 This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as bacterial pneumonia. A comparison of the PK profile of finafloxacin in plasma and lung ELF using different bronchoscopic ELF sampling techniques (BMS and BAL) is conducted.
NCT01910883 Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects Completed MerLion Pharmaceuticals GmbH Phase 1 This is the first time finafloxacin was administered to humans intravenously. The principal aim of this study was to obtain safety and tolerability data when finafloxacin was administered intravenously as single and multiple doses to healthy subjects.
NCT01928433 Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis Completed MerLion Pharmaceuticals GmbH Phase 2 The primary objective of this study is to evaluate the microbiological and clinical outcome of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Finafloxacin

Condition Name

Condition Name for Finafloxacin
Intervention Trials
Urinary Tract Infections 2
Helicobacter Infections 2
Dyspepsia 1
Urinary Tract Infection 1
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Condition MeSH

Condition MeSH for Finafloxacin
Intervention Trials
Urinary Tract Infections 3
Infection 2
Helicobacter Infections 2
Communicable Diseases 2
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Clinical Trial Locations for Finafloxacin

Trials by Country

Trials by Country for Finafloxacin
Location Trials
Germany 3
United States 2
Singapore 1
United Kingdom 1
Switzerland 1
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Trials by US State

Trials by US State for Finafloxacin
Location Trials
Arizona 2
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Clinical Trial Progress for Finafloxacin

Clinical Trial Phase

Clinical Trial Phase for Finafloxacin
Clinical Trial Phase Trials
Phase 2 3
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Finafloxacin
Clinical Trial Phase Trials
Completed 7
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Clinical Trial Sponsors for Finafloxacin

Sponsor Name

Sponsor Name for Finafloxacin
Sponsor Trials
MerLion Pharmaceuticals GmbH 7
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Sponsor Type

Sponsor Type for Finafloxacin
Sponsor Trials
Industry 7
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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Queensland Health
Cipla
Fuji
Fish and Richardson
Covington
Teva
Accenture

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