Official Title: “An Open-Label, Randomized, 2-Way Crossover Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

In this single-dose study conducted at a single center, the effect of food on the pharmacokinetics of levofloxacin was studied in 24 healthy men and women aged 18 to 55 years old. Subjects were assigned different treatments based on chance; both the researcher and the study participant knew the treatment being administered. The study consisted of 3 phases: a screening phase, an open-label treatment phase consisting of 2 treatment periods, and a post-treatment phase. Subjects who met the prestudy eligibility criteria were randomly assigned to 1 of 2 treatment sequence groups. In each treatment period, subjects were admitted to the study facility the evening before study drug administration and housed through 48 hours after dosing with study drug. Subjects received levofloxacin as a single oral dose of 500 mg under both fed (within 10 minutes after completion of a high-fat, high-caloric breakfast) and fasted (10-hour overnight fast) conditions according to their randomized treatment sequence. Each dosing day was separated by a washout period of at least 4 days. In each treatment period, pharmacokinetic blood samples were collected immediately prior to dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing for determination of plasma concentrations of levofloxacin. Safety evaluations, including adverse event monitoring, standard clinical laboratory evaluations (hematology, serum chemistry, and urinalysis), vital sign monitoring, and physical examinations were performed on Days 1 and 3 of each treatment period. The post-treatment phase consisted of safety evaluations peformed after collection of the final pharmacokinetic blood sampling in the second treatment period. Adverse events were monitored from the time of the first study-related procedure through completion of post-treatment study procedures, or until the time of early withdrawal from the study.

Levofloxacin solution administered as 2 single oral doses of 500 mg each, 1 in each treatment period, administered at least 4 days apart.

Intervention(s) in this Clinical Trial

• Drug: levofloxacin oral solution

Primary Measures

• Evaluation of the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing.

Secondary Measures

• Safety was assessed through vital sign monitoring, physicals, laboratory tests, and urinalysis on Days 1 and 3 and through the monitoring of adverse events throughout the study.

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 hepatits 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 clincal laboratory abnormalities
• Creatinine clearance <=80 mL/min
• Acute illness within 7 days
• Receipt of experimental drug or device within 60 days
• Pregnant or breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00601432

Study ID Number: CR010621

ClinicalTrials.gov Identifier: NCT00601432

Health Authority: United States: Food and Drug Administration

An open-label, randomized, 2-way crossover study to evaluate the effect of food on levofloxacin pharmacokinetics from an oral solution formulation