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

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