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Zyrtec

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
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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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00649857Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mgPHASE1 COMPLETED 18Nov 1, 2002Dec 1, 2002Apr 24, 20241 United States
NCT00650065Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mgPHASE1 COMPLETED 26Nov 1, 2002Dec 1, 2002Apr 24, 20241 United States
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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
1EXPERIMENTALCetirizine HCl Tablets 10 mg
2ACTIVE_COMPARATORZyrtec® 10 mg
Interventions
NameTypeDescription
Cetirizine HCl Tablets 10 mgDRUG10mg, single dose fed
Zyrtec® 10 mgDRUG10mg, single dose fed
Zyrtec® Tablets 10 mgDRUG10mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:United States
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