Who is sponsoring NCT01904162?

NCT01904162 is sponsored by MerLion Pharmaceuticals GmbH.

What condition does NCT01904162 study?

NCT01904162 studies Pharmacokinetic and Tolerability of Finafloxacin.

What drugs are being tested in NCT01904162?

Interventions: 400 mg finafloxacin (2 x 200 mg tablets).

What is the status of NCT01904162?

NCT01904162 is currently COMPLETED.

Last reviewed 2024-03-12 · How we verify

Determination of the Effect of Age and Gender on the Pharmacokinetics and Tolerability of a Single Dose of Finafloxacin-HCL in Healthy Volunteers

NCT01904162 Phase 1 COMPLETED

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.

Details

Lead sponsor	MerLion Pharmaceuticals GmbH
Phase	Phase 1
Status	COMPLETED
Enrolment	40
Start date	2010-02
Completion	2010-02

Conditions

Pharmacokinetic and Tolerability of Finafloxacin

Interventions

400 mg finafloxacin (2 x 200 mg tablets)

Primary outcomes

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.

Countries

United States