A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.

• 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 medications 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, and 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

• Nicotine use within 1 year

• Receipt of experimental drug or device within 60 days

• Pregnant or breastfeeding