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Zithromax

Phase 1

Infection | Small molecule | Other |Novartis AG|Last Updated: Mar 29, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00865670To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed ConditionsPHASE1 COMPLETED 38Aug 1, 2003Sep 1, 2003Mar 29, 2017 -
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Study Endpoints
Primary Endpoints
Bioequivalence according to US FDA guidelines
32 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAzithromycin Monohydrate 600mg Tablets
2ACTIVE_COMPARATORZithromax (azithromycin dihydrate)600mg Tablets
Interventions
NameTypeDescription
Azithromycin Monohydrate 600 mg TabletsDRUG -
Zithromax (azithromycin dihydrate) 600 mg TabletsDRUG -
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening Exclusion Criteria: * Positive test results for HIV or hepatitis B or C * Treatment for drug or alcohol dependence * Female subjects who are pregnant or ...

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