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

Bayer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Moxifloxacin (BAY12-8039)

Drug: Moxifloxacin (Avelox, BAY12-8039)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01073891

2009-017070-21 (EudraCT Number)

14413

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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