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CEFZIL

Phase 1

Undisclosed | Small molecule | Other |Teva Pharmaceutical Industries Limited|Trials Updated: Aug 20, 2024

CEFZIL development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2009

CEFZIL target and mechanism

ModalitySmall molecule

Also known as Cefzil

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

CEFZIL clinical trials

CEFZIL · 1 trial · 1 indication

Phase 1 1
NCT00840281Cefprozil 500 mg Tablets Under Fasting ConditionsHealthy
COMPLETED38 Analytics
PHASE1COMPLETED
Cefprozil 500 mg Tablets Under Fasting Conditions
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Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration)
Blood samples collected over a 12 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 12 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 12 hour period.

Bioequivalence based on AUC0-inf.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Cefzil® 500 mg tabletsDRUG1 x 500 mg, single-dose fasting
Cefprozil 500 mg TabletsDRUG1 x 500 mg, single-dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is no...

Countries:United States
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Frequently asked questions about CEFZIL

What is CEFZIL used for?

CEFZIL is a brand of cefprozil, an oral antibiotic. Its listed development program covers an undisclosed indication, and the only trial on record enrolled healthy adult volunteers rather than patients. The drug is studied as a small molecule and is not described as approved for any specific indication in this program.

Who makes CEFZIL?

CEFZIL is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the company associated with the CEFZIL brand and its listed oral suspension and tablet presentations.

What phase is CEFZIL in?

CEFZIL is listed at Phase 1. One trial has been completed and none are active, with a total enrollment of 38 participants. The program is investigational and remains in clinical development.

What clinical trials is CEFZIL in?

CEFZIL has one recorded trial, NCT00840281, titled Cefprozil 500 mg Tablets Under Fasting Conditions. It was a completed Phase 1 study of 38 healthy volunteers in the United States, randomized and active controlled, with participants aged 18 years and older.

Is CEFZIL the same as cefprozil?

Yes. CEFZIL is a brand name for cefprozil, and the listed alternative names include CEFZIL for Oral Suspension 250 mg/5mL, Cefzil 500 mg tablets, and Cefzil. Searches for any of these names refer to the same product.

What does CEFZIL target?

CEFZIL is a small molecule, and its listed development program does not specify a molecular target or target class. The completed Phase 1 trial, NCT00840281, evaluated cefprozil 500 mg tablets under fasting conditions in healthy volunteers rather than testing a named target.