A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: levofloxacin oral solution (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
Official title: An Open-Label, Randomized, 2-Way Crossover Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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 outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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 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
Locations and Contacts
Additional Information
An open-label, randomized, 2-way crossover study to evaluate the effect of food on levofloxacin pharmacokinetics from an oral solution formulation
Starting date: October 2002
Ending date: December 2002
Last updated: January 25, 2008
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