Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin, floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then periodically for 6 weeks after the last dose of study drug is taken

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Azithromycin; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Male or female

• Healthy on the basis of a pre-study physical examination, medical history, and the laboratory results of blood hematology, biochemistry, and urinalysis performed within 24 hours before the first dose

• Renal function tests must be within the normal laboratory reference ranges

• Normotensive with sitting (5 minutes) blood pressure between the range of 90 to 140 mmHg systolic, inclusive, and 50-90 mmHg diastolic, inclusive

• Normal temperature for at least 72 hours. Normal defined as >36.0 C (96.8 F) to <37.5 C (99.5 F)

• Weight as defined by BMI range of 18 to 32 kg/m2, inclusive

• Must have read and signed the informed consent document before the first study-related procedure indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• History of allergy or serious adverse reaction to levofloxacin or any other quinolone or to azithromycin or any other macrolide

• Clinically significant abnormal laboratory values

• Previous systemic antimicrobial therapy within 3 months of Study Entry for any reason

• Hospitalized for any cause within 3 months prior to Study Entry

• Current drug abuse, alcohol abuse, or homelessness

• Requirement for any prescription or non-prescription medication or supplements such as vitamins and herbal supplements, except for paracetamol (acetaminophen) for the treatment of headache and other pain, hormone replacement therapy, and birth control medication upon study entry and during study conduct

• Pregnancy or breastfeeding

• Has received an experimental drug or medical device within the previous 3 months or involvement in any other experimental protocol.