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Levofloxacin; Azithromycin

Phase 1

Healthy Volunteer | Small molecule | Other |Johnson & Johnson|Last Updated: May 19, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Clinical trial landscape

Levofloxacin; Azithromycin · 1 trial · 1 indication

Phase 1 1
NCT00821782Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic MedicationsHealthy Volunteer
COMPLETED143 Analytics
PHASE1COMPLETED
Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications
Healthy Volunteer
NCT00821782143
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Study Endpoints

Primary Endpoints

The primary endpoint is the emergence or worsening of bacterial resistance in the mouth and throat through six weeks after completion of the antibiotic

Secondary Endpoints

All bacterial species cultured from the mouth and throat will be recorded. Each bacterial species seen at baseline, the proportion of subjects in which there was bacterial resistance will be summarized.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Levofloxacin; AzithromycinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

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 ...

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