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azithromycin immediate release

Phase 2

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jun 8, 2011

azithromycin immediate release 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

azithromycin immediate release clinical trials

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
PharmacokineticsUnlock trial analytics

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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Frequently asked questions about azithromycin immediate release

What is azithromycin immediate release?

Azithromycin immediate release is a small molecule form of azithromycin, the macrolide antibiotic also marketed as Zithromax. Pfizer, Inc. (ticker PFE) is the developer. The immediate release designation refers to the standard tablet formulation that releases the drug promptly after dosing, as opposed to a sustained release version.

Who makes azithromycin immediate release?

Pfizer, Inc., which trades under the ticker PFE, is the developer of azithromycin immediate release. The drug is also known as Zithromax. Pfizer conducted the clinical work described for this formulation, including a pharmacokinetic study in cancer patients requiring lung surgery.

What phase is azithromycin immediate release in?

Azithromycin immediate release has been studied in Phase 2 clinical development. The recorded trial is completed, and no active trials are listed. The program has one completed Phase 2 study with 66 enrolled participants. It is an investigational use in this pharmacokinetic setting rather than a newly approved product.

What clinical trials is azithromycin immediate release in?

Azithromycin immediate release was evaluated in one completed Phase 2 trial, NCT00644176. The study was a randomized, open label, controlled pharmacokinetic trial comparing a single 2 gram dose of azithromycin sustained release with a commercial 500 mg azithromycin tablet in cancer patients requiring lung surgery. It enrolled 66 participants in Italy.

Is azithromycin immediate release the same as Zithromax?

Yes, azithromycin immediate release is also known as azithromycin immediate release (Zithromax). Zithromax is the brand name associated with this azithromycin formulation developed by Pfizer, Inc. (ticker PFE). The immediate release description distinguishes the standard tablet from the sustained release 2 gram version tested in the same pharmacokinetic study.

What was studied in the azithromycin immediate release trial?

Trial NCT00644176 examined the pharmacokinetics of azithromycin in cancer patients who required lung surgery. It was a randomized, open label, controlled Phase 2 study comparing a single 2 gram dose of azithromycin sustained release with a commercial 500 mg azithromycin tablet. The trial enrolled 66 adults in Italy and is completed.