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Azithromycin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Azithromycin · 2 trials · 1 indication

Phase 1 2
NCT00649935Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mgHealthy
COMPLETED54 Analytics
NCT00650273Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mgHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
Healthy
NCT0064993554
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PHASE1COMPLETED
Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
Healthy
NCT0065027354
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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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
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Eligibility Criteria

Age Range18 Years to 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
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