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azithromycin immediate release

Phase 2

Pharmacokinetics | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 8, 2011

Target and mechanism

ModalitySmall molecule

Also known as azithromycin immediate release (Zithromax)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

azithromycin immediate release · 1 trial · 1 indication

Phase 2 1
NCT00644176A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung SurgeryPharmacokinetics
COMPLETED66 Analytics
PHASE2COMPLETED
A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery
Pharmacokinetics
NCT0064417666
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Study Endpoints

Primary Endpoints

Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
2, 4, 8, 12, 16, 24, 48, and 72 hours postdose

Secondary Endpoints

12-lead electrocardiograms (ECGs)
Screening and 72 hours postdose
adverse events (AEs)
Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
safety laboratory tests
Treatment day 0 and 72 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
azithromycin immediate release (Zithromax)DRUGazithromycin IR 500 mg tablet by mouth for 1 dose
placeboOTHERplacebo
azithromycin SRDRUG2.0 g by mouth in the form of liquid for 1 dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Inclusion criteria were hospitalized subjects diagnosed with lung cancer that had consented to surgery requiring lung resection who had a life expectancy of \>6 months. Exclusion Criteria: Key exclusion criteria were antibiotic prophylaxis prior to surgery, diffuse, non-infect...

Countries:Italy
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