A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study was to evaluate the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Levofloxacin; Ofloxacin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Men and women

• Aged 18 to 55 years

• BMI between 18 and 30 kg/m2

• No prescription or over-the-counter medication for previous 14 days

• Negative tests for drug and alcohol abuse

• HIV, hepatitis B and hepatitis C

• and Healthy based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, antibody screens, and clinical laboratory evaluations

Exclusion Criteria:

• Allergic reaction to quinolones

• clinically significant ECG or clinical laboratory abnormalities

• creatinine clearance <=80 mL/min

• acute illness within 7 days

• receipt of experimental drug or device within 60 days

• pregnant or breastfeeding