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Fixed combination of Azithromycin and Chloroquine

Phase 1

Malaria | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 21, 2009

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

Fixed combination of Azithromycin and Chloroquine · 1 trial · 1 indication

Phase 1 1
NCT00844207A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And ChloroquineMalaria
COMPLETED40 Analytics
PHASE1COMPLETED
A Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine
MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

AUClast and Cmax of azithromycin and chloroquine for each treatment.
up to 96 hours post dose on Day 5

Secondary Endpoints

Tmax of azithromycin and chloroquine for each treatment cohort.
up to 96 hours post dose on Day 5
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALTwo of the fixed combination tablets each containing 250 mg of azithromycin and 155 mg of chloroquine base.
Treatment BACTIVE_COMPARATORA single tablet containing 500 mg of azithromycin and a single tablet containing 300 mg of chloroquine base.

Interventions

NameTypeDescription
Fixed combination of Azithromycin and ChloroquineDRUGPfizer will provide the study medications, fixed combination azithromycin/chloroquine tablets (250 mg/155 mg, base), The study treatment is single dose.
Azithromycin and ChloroquineDRUGPfizer will provide Zithromax (500 mg) and Aralen (500 mg containing 300 mg chloroquine base). The study treatment is single dose.
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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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Competitive Landscape -Malaria 6 trials

Frequently asked questions about Fixed combination of Azithromycin and Chloroquine

What is the fixed combination of Azithromycin and Chloroquine used for?

The fixed combination of Azithromycin and Chloroquine is used for malaria. It is a small molecule drug being developed by Pfizer, Inc. (PFE) for the treatment of this infectious disease. The combination is currently in Phase 1 clinical development.

What does the fixed combination of Azithromycin and Chloroquine target?

The fixed combination of Azithromycin and Chloroquine contains two active ingredients: azithromycin, a macrolide antibiotic, and chloroquine, an antimalarial agent. Chloroquine targets the malaria parasite, while azithromycin provides antibacterial activity. The combination is being studied for its potential in treating malaria.

Who makes the fixed combination of Azithromycin and Chloroquine?

The fixed combination of Azithromycin and Chloroquine is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for malaria.

What phase is the fixed combination of Azithromycin and Chloroquine in?

The fixed combination of Azithromycin and Chloroquine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is the fixed combination of Azithromycin and Chloroquine in?

The fixed combination of Azithromycin and Chloroquine has been studied in one completed Phase 1 clinical trial, identified as NCT00844207. This trial, conducted in the United States, enrolled 40 healthy volunteers and was designed to estimate the relative bioavailability of the fixed combination tablets compared to co-administered individual tablets of azithromycin and chloroquine.

Is the fixed combination of Azithromycin and Chloroquine the same as azithromycin and chloroquine given separately?

The fixed combination of Azithromycin and Chloroquine is a tablet formulation that combines both drugs into a single dose, whereas azithromycin and chloroquine can also be given as separate tablets. A Phase 1 study (NCT00844207) was conducted to compare the relative bioavailability of the fixed combination tablets to co-administered individual tablets of azithromycin and chloroquine.