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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00601432
First received: December 6, 2007
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
The Focus of This Study Was to Assess the Effect of Food Following a Single Oral Dose of Levofloxacin Solution.
Drug: levofloxacin oral solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, 2-way Crossover Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome 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 Outcome 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.

Enrollment: 24
Study Start Date: October 2002
Study Completion Date: December 2002
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 performed 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601432

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00601432     History of Changes
Other Study ID Numbers: CR010621
Study First Received: December 6, 2007
Last Updated: April 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
open-label
randomized
crossover
food effect

Additional relevant MeSH terms:
Levofloxacin
Ofloxacin
Pharmaceutical Solutions
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014