Trial · NCT01904162
Effect of Age and Gender on the PK and Tolerability of Finafloxacin
NCT01904162, Phase 1, Completed, MerLion Pharmaceuticals GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Age and Gender on the PK and Tolerability of Finafloxacin. Trials, record NCT01904162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01904162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Age and Gender on the PK and Tolerability of Finafloxacin
- NCT number
- NCT01904162
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Conditions
- Pharmacokinetic and Tolerability of Finafloxacin
- Interventions
- 400 mg finafloxacin (2 x 200 mg tablets)
- First posted
- 2013-07-22
- Last updated
- 2024-03-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic | Day 1 | The primary PK endpoints of the study were the 90% confidence interval (CI) for the ratio of the population geometric means of the PK parameters AUC0-t, AUC0-24, AUC0-inf, and Cmax in plasma and the 90% CI for the ratio of the population geometric means of the PK parameters CumAe0-24 and Rmax in urine. |
| Secondary | Safety and tolerability | Day 1 | 1. The number and severity of treatment-emergent adverse events (TEAEs) following single doses of finafloxacin for each population in the study 2. Changes from baseline for each population for safety clinical laboratory parameters, electrocardiographs, vital signs, and physical examinations |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01904162
GET https://conductscience.org/api/trials/v1/NCT01904162/registered