Trial · NCT01910883
Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
NCT01910883, Phase 1, Completed, MerLion Pharmaceuticals GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects. Trials, record NCT01910883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01910883
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
- NCT number
- NCT01910883
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 58 participants, actual
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Conditions
- Healthy
- Interventions
- Finafloxacin i.v. solution 200 mg, Finafloxacin i.v. solution 400 mg, Finafloxacin i.v. solution 600 mg, Finafloxacin i.v. solution 800 mg, Finafloxacin i.v. solution 1000 mg, Placebo i.v. solution
- First posted
- 2013-07-30
- Last updated
- 2013-07-30
- Other registries' IDs
- eudract:2010-021555-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety | 1 to 7 days | The primary objective was to evaluate the safety and tolerability of single and multiple intravenous (IV) doses of finafloxacin in healthy subjects. The safety evaluation includes the descriptive display and analysis of adverse events after single and multiple doses for 7 days of intravenously administered finafloxacin. The frequency of adverse events is evaluated for all casualties and for drug related adverse events. Comparisons between the placebo and verum groups are provided in descriptive manner. In addition the evaluation of clinical laboratory data, vital signs, electrocardiography data, physical examination, local tolerability is provided. |
| Secondary | Pharmacokinetic parameters of finafloxacin in plasma and urine samples from healthy subjects using non compartmental procedures | 1 to 7 days | The pharmacokinetic parameters determined for single dose are: AUC, Cmax, tlast, t½, CL, VZ, VSS, amount of drug excreted in urine, fraction of dose excreted in urine, renal clearance. The pharmacokinetic parameters determined for multiple dose are: AUC, Cmax, tmax, t½, observed accumulation ratio, predicted accumulation ratio, linearity ratio, CL, VZ, VSS, amount of drug excreted in urine, fraction of dose excreted in urine, renal clearance. In addition, dose and body weight normalised values (norm) for AUC 0-τ, AUC0- tlast, AUC and Cmax were determined by dividing the original pharmacokinetic parameter by dose per kg body weight. Body weight normalised values \[norm\] for CL, VZ and CLR were calculated by dividing the original pharmacokinetic parameter by body weight. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28784673 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01910883
GET https://conductscience.org/api/trials/v1/NCT01910883/registered