Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults

Bayer24 enrolled

Overview

The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is to see how the body absorbs, distributes and gets rid of the study drug. The absorption of the drug administered in a different dosage form may be altered due to the influence of different excipients used. The safety of moxifloxacin when administered as an oral liquid formulation will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects; * Age: 18 to 55 years (inclusive) * Body mass index (BMI): above/equal 18 and below/equal 30 kg/m²; * Women of childbearing age must have a negative pregnancy test and must use adequate contraception throughout the study and for 4 weeks afterwards Exclusion Criteria: * Clinically relevant findings in the ECG * Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * Known hypersensitivity to moxifloxacin, other quinolones or to any of the excipients * Known severe allergies, non-allergic drug reactions, or multiple drug allergies * Relevant diseases within the last 4 weeks prior to the first study drug administration * Febrile illness within 1 week before the first study drug administration * Patients with a history of tendon disease/disorder related to quinolone treatment. * Congenital or documented acquired QT prolongation * Regular use of medicines (with the exception of contraceptives) * Pregnancy or lactation * Regular use of therapeutic or recreational drugs * Smoking more than 25 cigarettes daily * Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form * Suspicion of drug or alcohol abuse * Special diets preventing the subjects from eating the standard meals during the study * Regular daily consumption of more than 1 L of xanthin-containing beverages * Donation of more than 100 mL of blood within 4 weeks before the first study drug administration or of approximately 500 mL in the preceding 3 months

Outcomes

Primary Outcomes

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Moxifloxacin after a Single Dose

AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.