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azithromycin microsphere

Phase 1

Malaria Prophylaxis | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 25, 2010

Target and mechanism

ModalitySmall molecule

Also known as azithromycin (AZ) microsphere

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

azithromycin microsphere · 1 trial · 1 indication

Phase 1 1
NCT01100060A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult SubjectsMalaria Prophylaxis
COMPLETED40 Analytics
PHASE1COMPLETED
A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects
Malaria Prophylaxis
NCT0110006040
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Study Endpoints

Primary Endpoints

AUClast of azithromycin and chloroquine
Through Day 5

Secondary Endpoints

Tmax and Cmax of azithromycin and chloroquine.
Through Day 5
AUClast, Tmax, and Cmax of desethylchloroquine.
Through Day 5
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALCo-administer the test chloroquine (CQ) formulation (620 mg CQ base) plus microsphere azithromycin (AZ) (2000 mg) on Day 1.
Group 2ACTIVE_COMPARATORCo-administer the individual tablets of CQ 2 x 500 mg (600 mg CQ base) tablets plus AZ IR 4 x 500 mg tablets on Day 1.

Interventions

NameTypeDescription
azithromycin (AZ) microsphereDRUGAZ microsphere (2000 mg) single dose on Day 1.
test chloroquine (CQ) formulationDRUGTest CQ formulation, 620 mg CQ base, single dose on Day 1.
azithromycin (AZ)DRUGAZ IR 4 x 500 mg tablets, single dose on Day 1.
chloroquine (CQ)DRUGCQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG ...

Countries:United States
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