CLINICAL TRIALS PROFILE FOR FINAFLOXACIN
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All Clinical Trials for FINAFLOXACIN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00483158 ↗ | 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. |
| 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 | 2008-10-01 | 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 | 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. |
| NCT01904162 ↗ | 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. |
| NCT01907867 ↗ | Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin | Completed | MerLion Pharmaceuticals GmbH | Phase 1 | 2012-01-01 | 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 | 2010-09-01 | 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 | 2012-12-01 | 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. Finafloxacin shows increased activity in an acidic environment which is associated with indications such as uUTI and cUTI. Given the acidic pH of urine and concentration of finafloxacin excreted via the urinary tract in humans it should be proven if the finafloxacin treatments offer significant advantages over the currently available treatments for UTI. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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