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Cefprozil

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Mar 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

Cefprozil · 2 trials · 1 indication

Phase 1 2
NCT00881426To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT00881855To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed ConditionsHealthy
COMPLETED35 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
Healthy
NCT0088142626
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PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
Healthy
NCT0088185535
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Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
16 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCefprozil 500 mg Tablets (Sandoz GmbH)
2ACTIVE_COMPARATORCefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)

Interventions

NameTypeDescription
Cefprozil 500 mg Tablets (Sandoz GmbH)DRUG -
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)DRUG -
Cefprozil 500 mg Tablets (Sandoz, GmbH)DRUG -
Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)DRUG -
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Eligibility Criteria

Age Range20 Years to 54 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Frequently asked questions about Cefprozil

What is Cefprozil used for?

Cefprozil is a small molecule antibiotic being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials evaluating the relative bioavailability of Cefzil 500 mg cefprozil tablets under fasting and fed conditions. The drug is investigational and not yet approved for any indication.

Who makes Cefprozil?

Cefprozil is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting Phase 1 clinical trials to assess the bioavailability of the drug in healthy volunteers.

What phase is Cefprozil in?

Cefprozil is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is Cefprozil in?

Cefprozil has two completed Phase 1 trials: NCT00881426, which assessed the relative bioavailability of Cefzil 500 mg cefprozil tablets under fasting conditions with 26 participants, and NCT00881855, which assessed bioavailability under fed conditions with 35 participants. Both trials enrolled healthy adults.

How does Cefprozil work?

Cefprozil is a cephalosporin antibiotic that works by inhibiting bacterial cell wall synthesis, leading to bacterial cell death. It is being studied for its bioavailability in healthy volunteers as part of Phase 1 clinical development.