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Ciprofloxacin

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Ciprofloxacin development status

FDA approval on record Dec 13, 2002
Approval holderBayer Hlthcare
ApplicationNDA021473
Highest phase Phase 4 run by Bayer (NCT00669994)
Phase scored for VTRSPhase 1
Registered trials 21 across 11 sponsors since Apr 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment107

FDA Designations

No designations recorded

Ciprofloxacin clinical trials

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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Frequently asked questions about Ciprofloxacin

What is Ciprofloxacin?

Ciprofloxacin is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is not disclosed. The drug is also known as Ciprofloxacin Extended-Release Tablets 1000 mg and Ciprofloxacin Extended-Release Tablets 500 mg.

Who makes Ciprofloxacin?

Ciprofloxacin is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the clinical program for this extended-release tablet formulation.

What phase is Ciprofloxacin in?

Ciprofloxacin is in Phase 1 clinical development. All three of its recorded trials are Phase 1 studies, and all three have been completed. No active trials are currently listed for this program.

What clinical trials is Ciprofloxacin in?

Ciprofloxacin has been evaluated in three completed Phase 1 trials: NCT00650351, a food study of the 1000 mg extended-release tablet; NCT00649662, a fasting study of the 1000 mg tablet; and NCT00649155, a fasting study of the 500 mg tablet. All enrolled healthy adult volunteers in the United States.

Is Ciprofloxacin the same as Ciprofloxacin Extended-Release Tablets?

Yes. Ciprofloxacin is also known as Ciprofloxacin Extended-Release Tablets 1000 mg and Ciprofloxacin Extended-Release Tablets 500 mg. These names refer to the same extended-release tablet formulations studied in the Phase 1 program.

How many patients were enrolled in Ciprofloxacin trials?

The three completed Phase 1 trials of Ciprofloxacin enrolled a total of 107 participants. NCT00650351 enrolled 35, NCT00649662 enrolled 36, and NCT00649155 enrolled 36. All participants were healthy volunteers aged 18 years and older, and the studies were active-controlled.