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Ciprofloxacin

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 Trials3
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

Ciprofloxacin · 3 trials · 1 indication

Phase 1 3
NCT00649155Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mgHealthy
COMPLETED36 Analytics
NCT00649662Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mgHealthy
COMPLETED36 Analytics
NCT00650351Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mgHealthy
COMPLETED35 Analytics
PHASE1COMPLETED
Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
HealthyUnlock trial analytics

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 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 (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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