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Cipro

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
NCT00649155Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mgPHASE1 COMPLETED 36Nov 1, 2005Nov 1, 2005Apr 24, 20241 United States
NCT00649662Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mgPHASE1 COMPLETED 36Oct 1, 2005Oct 1, 2005Apr 24, 20241 United States
NCT00650351Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mgPHASE1 COMPLETED 35Oct 1, 2005Oct 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
1EXPERIMENTALCiprofloxacin Extended-Release Tablets 500 mg
2ACTIVE_COMPARATORCipro® XR Tablets 500 mg
Interventions
NameTypeDescription
Ciprofloxacin Extended-Release Tablets 500 mgDRUG500mg, single dose fasting
Cipro® XR Tablets (500 mgDRUG500mg, single dose fasting
Ciprofloxacin Extended-Release Tablets 1000 mgDRUG1000mg, single dose fasting
Cipro® XR Tablets 1000 mgDRUG1000mg, 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 (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the eveni...

Countries:United States
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