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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00602589
First received: January 7, 2008
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
The Focus of the Study is to Determine the Bioequivalence of Three Formulations of Levofloxacin.
Drug: Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, 3-way Crossover Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference.

Secondary Outcome Measures:
  • Assessment of the bioequivalence of the oral suspension and solution formulations, on Days 1, 2, and 3, using the suspension formulation as the reference.

Enrollment: 72
Study Start Date: October 2002
Study Completion Date: November 2002
Detailed Description:

In this single-dose study conducted at at single center, 3 oral formulations of levofloxacin (tablet, suspension, and solution) were assessed for their bioequivalence in 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 a screening period, 3 open-label treatment periods separated by washout periods of at least 4 days between doses, and a post-treatment period. Subjects received a single dose of all 3 study formulations, administered as a single dose of each formulation on Day 1 of each treatment period. Blood samples were collected on Days 1, 2, and 3 of each treatment period immediately before 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 measurement of levofloxacin concentration. Subjects were admitted to the study site prior to dosing and remained through the 48-hour measurements on Day 3. The post-treatment period included physical examination and clinical laboratory testing to ensure subject safety before being discharged from the study. Safety evaluations, including adverse event monitoring, standard clinical laboratory evaluations (hematology, serum chemistry, and urinalysis), vital sign monitoring, and physical examinations, were monitored throughout the study.

Two cohorts of 36 subjects each were enrolled in the study. The first cohort received a single dose of study drug and completed Period 1; the study was then stopped and reinitiated. Subjects from the first cohort completed early termination procedures; their data were included in safety analyses, however, no blood samples for levofloxacin concentrations were analyzed or included in pharmacokinetic analysis. Thirty-four subjects in the second cohort completed all study procedures. Levofloxacin oral suspension (125 mg/5 mL), levofloxacin oral solution (125 mg/5 mL), and levofloxacin tablet (500 mg) administered on Day 1 of each treatment period.

  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 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
  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: NCT00602589

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: NCT00602589     History of Changes
Other Study ID Numbers: CR011395
Study First Received: January 7, 2008
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 29, 2014