Status:
COMPLETED
Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications
Lead Sponsor:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a randomized, open-label, single center, exploratory, Phase 1 study to explore changes and resistance patterns of bacteria in the oral flora of healthy male and female adult subjects. The stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00821782
Start Date
June 1 2006
End Date
September 1 2006
Last Update
May 19 2011
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