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Adoxa

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 Trials3
Total Enrollment107
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00647959Fasting Study of Doxycycline Monohydrate Tablets 150 mg and Adoxa Tablets 150 mgPHASE1 COMPLETED 36Mar 1, 2006Apr 1, 2006Apr 24, 20241 United States
NCT00648180Food Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mgPHASE1 COMPLETED 36Jul 1, 2005Aug 1, 2005Apr 24, 20241 United States
NCT00649571Fasting Study of Doxycycline Monohydrate Tablets 100 mg and Adoxa Tablets 100 mgPHASE1 COMPLETED 35Jul 1, 2005Jul 1, 2005Apr 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
1EXPERIMENTALDoxycycline Tablets, 150mg
2ACTIVE_COMPARATORAdoxa Tablets 150 mg
Interventions
NameTypeDescription
Doxycycline Tablets, 150mgDRUG150mg, single dose fasting
Adoxa Tablets 150 mgDRUG150mg, single dose fasting
Doxycycline Monohydrate Tablets 100 mgDRUG100mg, single dose fed
Adoxa Tablets 100 mgDRUG100mg, single dose fed
Doxycycline Monohydrate Tablets (100 mgDRUG100mg, 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/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 21 days prior to the start of the study and on the ev...

Countries:United States
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