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Levofloxacin; Azithromycin

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: May 19, 2011

Levofloxacin; Azithromycin development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment143

FDA Designations

No designations recorded

Levofloxacin; Azithromycin clinical trials

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 VolunteerUnlock trial analytics

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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Frequently asked questions about Levofloxacin; Azithromycin

What is levofloxacin and azithromycin?

Levofloxacin and azithromycin are two antibiotic medications studied together in a Phase 1 trial. The trial evaluated bacteria in the mouth and throat of healthy adults before and after administration of either antibiotic. Both are small molecule drugs. The study was sponsored by Johnson & Johnson.

Who is developing levofloxacin and azithromycin?

Johnson & Johnson, ticker JNJ, is the developer of the levofloxacin and azithromycin study. The company sponsored the Phase 1 trial evaluating these antibiotics in healthy volunteers.

What phase is the levofloxacin and azithromycin trial in?

The levofloxacin and azithromycin trial is in Phase 1. It has been completed, with 143 participants enrolled. The study was randomized but not double-blind and used an uncontrolled design. It is not currently active.

What clinical trial is levofloxacin and azithromycin in?

Levofloxacin and azithromycin were evaluated in clinical trial NCT00821782, titled "Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications." The trial enrolled 143 healthy volunteers aged 18 years and older and has been completed.

What is levofloxacin and azithromycin used for?

Levofloxacin and azithromycin are antibiotics. In the completed Phase 1 trial, they were administered to healthy adults to evaluate bacteria in the mouth and throat before and after treatment. The specific indications for this combination are not disclosed.