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Cefprozil

Phase 1

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Mar 29, 2017

Cefprozil development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment105

FDA Designations

No designations recorded

Cefprozil clinical trials

Cefprozil · 4 trials · 1 indication

Phase 1 4
NCT00881400To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed ConditionsHealthy
COMPLETED24 Analytics
NCT00881153To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.Healthy
COMPLETED20 Analytics
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 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
HealthyUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)
2ACTIVE_COMPARATORCefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)

Interventions

NameTypeDescription
Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)DRUG -
Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)DRUG -
Cefprozil 250 mg/5 ml Oral Suspension (Sandoz GmbH)DRUG -
Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb)DRUG -
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 Range18 Years to 55 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?

Cefprozil is a small molecule drug developed by Novartis AG (ticker NVS). It has been studied in Phase 1 clinical trials, with four completed trials enrolling a total of 105 participants. The trials were conducted in healthy volunteers and evaluated bioavailability of cefprozil tablets and oral suspension formulations under fed and fasting conditions.

Who makes Cefprozil?

Cefprozil is developed by Novartis AG, which trades under the ticker NVS. The drug has been studied in Phase 1 trials, and the tested formulations include Cefprozil 500 mg tablets and Cefprozil 250 mg/5 ml oral suspension. All four listed trials are completed.

What phase is Cefprozil in?

Cefprozil is in Phase 1 clinical development. Four Phase 1 trials have been completed, with no active trials currently listed. The completed studies enrolled 105 participants total and were conducted in healthy volunteers. The trials were randomized and active controlled, though not double blind.

What clinical trials is Cefprozil in?

Cefprozil has been evaluated in four completed Phase 1 trials: NCT00881855, NCT00881426, NCT00881400, and NCT00881153. These trials assessed the relative bioavailability of Cefzil 500 mg cefprozil tablets and Cefzil 250 mg/5 ml cefprozil oral suspension under fed and fasting conditions in healthy volunteers.

Is Cefprozil the same as Cefzil?

Cefprozil is also known by the brand name Cefzil, which appears in the trial titles for the 500 mg tablets and 250 mg/5 ml oral suspension. Additional alternative names include Cefprozil 250 mg/5 ml Oral Suspension and Cefprozil 500 mg Tablets, both associated with Sandoz formulations.

What is Cefprozil used for?

Cefprozil has been studied in Phase 1 clinical trials involving healthy volunteers, with the indications listed as undisclosed. The completed trials focused on demonstrating the relative bioavailability of cefprozil tablets and oral suspension formulations under fed and fasting conditions. No approved indication is specified in the available development information.