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kg azithromycin, kg azithromycin IR

Phase 2

Acute Otitis Media | Unknown | ENT |Pfizer, Inc.|Last Updated: Feb 18, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

kg azithromycin, kg azithromycin IR · 1 trial · 1 indication

Phase 2 1
NCT00796224Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis MediaAcute Otitis Media
COMPLETED38 Analytics
PHASE2COMPLETED
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
Acute Otitis MediaUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
Predose/0 to 72 Hours

AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.

Secondary Endpoints

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)
Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Azithromycin
Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin
Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1.ACTIVE_COMPARATOR60 mg/kg azithromycin ER (Extended Release)arm
2.ACTIVE_COMPARATOR30 mg/kg azithromycin IR (Immediate Release) arm

Interventions

NameTypeDescription
60 mg/kg azithromycin ERDRUGsubjects taken 60 mg/kg azithromycin ER
30 mg/kg azithromycin IRDRUGsubjects taken 30 mg/kg azithromycin IR (Immediate Release)
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Eligibility Criteria

Age Range6 Months to 11 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects age 6 months to \< 12 years. * Have clinical signs/symptoms of acute otitis media in at least one ear. * Parent(s)/legal guardian(s) provide written informed consent. Exclusion Criteria: * Clinical significant other disease. * Recent use of investigational drugs, pr...

Countries:Costa Rica
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Frequently asked questions about kg azithromycin, kg azithromycin IR

What is 1 mg, 5 mg, 10 mg used for?

1 mg, 5 mg, 10 mg is an investigational drug being developed by Pfizer, Inc. (PFE). It is being studied for use in neoplasms, non-Hodgkin lymphoma, meningococcal vaccine, growth disorder, hypercholesterolemia, and non-squamous lung cancer. The drug is currently in Phase 1 clinical development.

Who makes 1 mg, 5 mg, 10 mg?

1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for multiple indications including neoplasms and growth disorder.

What phase is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for conditions such as neoplasms, non-Hodgkin lymphoma, and growth disorder.

What clinical trials is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791 and NCT00039910, which evaluated its safety and efficacy in preventing thrombocytopenia in patients with neoplasms and lymphoma. These trials were Phase 3 and have been completed.

Is 1 mg, 5 mg, 10 mg the same as PN-152,243?

1 mg, 5 mg, 10 mg is associated with the investigational drug PN-152,243, also referred to as PN-196,444. Clinical trials such as NCT00037791 and NCT00039910 studied the safety and efficacy of PN-152,243/PN-196,444 in preventing thrombocytopenia.