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Cefadroxil

Phase 3

Undisclosed | Small molecule | Other |Teva Pharmaceutical Industries Limited|Trials Updated: Aug 19, 2024

Cefadroxil development status

Highest phase Phase 3 run by AbbVie (NCT02814916)
Phase scored for TEVAPhase 1
Registered trials 1 across 1 sponsor since Jun 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Cefadroxil clinical trials

Cefadroxil · 2 trials · 1 indication

Phase 1 2
NCT00834275Cefadroxil 500 mg Capsules Under Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT00835081Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.Healthy
COMPLETED26 Analytics
PHASE1COMPLETED
Cefadroxil 500 mg Capsules Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
HealthyUnlock trial analytics

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
Cefadroxil 500 mg CapsulesDRUG1 x 500 mg
DURICEF® capsules 500 mgDRUG1 x 500 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening. * Body mass index (BMI= weight/height2 greater than or equal to 19kg/m2 and less than or equal to 30kg/m2. * Availability o...

Countries:United StatesCanada
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Frequently asked questions about Cefadroxil

What is Cefadroxil?

Cefadroxil is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It has been studied in Phase 1 clinical trials involving healthy adult volunteers. The specific therapeutic indications for this asset are undisclosed.

Who makes Cefadroxil?

Cefadroxil is made by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker symbol TEVA. Teva is responsible for the development and clinical evaluation of this small molecule asset.

What phase is Cefadroxil in?

Cefadroxil is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The total enrollment across these completed studies was 52 participants.

What clinical trials is Cefadroxil in?

Cefadroxil has been evaluated in two completed Phase 1 trials: NCT00835081, titled Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects, and NCT00834275, titled Cefadroxil 500 mg Capsules Under Fasting Conditions. Both enrolled 26 participants in the United States and Canada.