Recent Updates
Recently added Catalysts

Zithromax

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00649935Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mgPHASE1 COMPLETED 54May 1, 2005Jun 1, 2005Apr 24, 20241 United States
NCT00650273Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mgPHASE1 COMPLETED 54Apr 1, 2005May 1, 2005Apr 24, 20241 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAzithromycin Tablets 600 mg
2ACTIVE_COMPARATORZithromax® Tablets 600 mg
Interventions
NameTypeDescription
Azithromycin Tablets 600 mgDRUG600mg, single dose fed
Zithromax® Tablets 600 mgDRUG600mg, single dose fed
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ...

Countries:United States
Unlock Eligibility Criteria