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Cipro

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

Cipro · 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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Frequently asked questions about Cipro

What is Cipro used for?

Cipro is a small molecule drug being developed by Viatris Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating ciprofloxacin extended-release tablets. The drug is investigational and has not been approved for any indication.

Who makes Cipro?

Cipro is developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.

What phase is Cipro in?

Cipro is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three completed trials were Phase 1 studies conducted in healthy volunteers in the United States.

What clinical trials is Cipro in?

Cipro has three completed Phase 1 clinical trials: NCT00649155, NCT00649662, and NCT00650351. These studies evaluated ciprofloxacin extended-release tablets at doses of 500 mg and 1000 mg, comparing them to Cipro XR tablets under fasting and fed conditions in healthy volunteers.

Is Cipro the same as ciprofloxacin?

Cipro is a brand name for ciprofloxacin, a fluoroquinolone antibiotic. The clinical trials listed compare ciprofloxacin extended-release tablets to Cipro XR tablets, indicating that Cipro refers to the reference product. The drug is being studied in healthy volunteers.