Recent Updates
Recently added Catalysts

Fixed combination of Azithromycin and Chloroquine

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 ChloroquinePHASE1 COMPLETED 40Feb 1, 2009Apr 1, 2009Apr 21, 20091 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria
Competitive Landscape -Malaria 8 trials