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A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single and Multiple Oral Doses of Finafloxacin Hydrochloride in Healthy Subjects and a Study of H. Pylori Treatment in Healthy Carriers
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.
Details
| Lead sponsor | MerLion Pharmaceuticals GmbH |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 95 |
| Start date | 2007-08 |
| Completion | 2008-05 |
Conditions
- Helicobacter Infections
- Urinary Tract Infection
Interventions
- Finafloxacin hydrochloride
Primary outcomes
- To evaluate the safety and tolerability of single and multiple oral doses of Finafloxacin HCl by assessing adverse events, physical examinations, clinical chemistry examination, hematology, ECG and urinalysis. — 7 days
Countries
Switzerland