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Cefdinir

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 Trials3
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Cefdinir · 3 trials · 1 indication

Phase 1 3
NCT00882154To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed ConditionsHealthy
COMPLETED28 Analytics
NCT00882700To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting ConditionsHealthy
COMPLETED28 Analytics
NCT00883883To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed ConditionsHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
Healthy
NCT0088215428
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PHASE1COMPLETED
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
Healthy
NCT0088270028
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PHASE1COMPLETED
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
Healthy
NCT0088388340
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Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCefdinir 300 mg Capsule (Sandoz, Austria)
2ACTIVE_COMPARATOROmnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Interventions

NameTypeDescription
Cefdinir 300 mg Capsule (Sandoz, Austria)DRUG -
Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)DRUG -
Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)DRUG -
Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)DRUG -
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Eligibility Criteria

Age Range18 Years to 56 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 Cefdinir

What is Cefdinir used for?

Cefdinir is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials focused on demonstrating bioequivalence of different formulations. The drug is being developed by Novartis AG (NVS).

Who makes Cefdinir?

Cefdinir is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of Cefdinir formulations compared to reference products.

What phase is Cefdinir in?

Cefdinir is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers. Three Phase 1 trials have been completed, with no active trials currently ongoing.

What clinical trials is Cefdinir in?

Cefdinir has been studied in three completed Phase 1 trials: NCT00882154, NCT00882700, and NCT00883883. These trials enrolled a total of 96 healthy volunteers and were designed to demonstrate the relative bioequivalence of Cefdinir compared to Omnicel or Omnicef formulations under fed and fasting conditions.

Is Cefdinir the same as Omnicef?

Cefdinir is being studied as a generic or alternative formulation to Omnicef. The clinical trials compare Cefdinir to Omnicef 300 mg capsules and Omnicef 250 mg/5 ml oral suspension to demonstrate bioequivalence, meaning Cefdinir is intended to be therapeutically equivalent to Omnicef.