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Cefadroxil

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

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

Clinical trial landscape

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 used for?

Cefadroxil is an antibiotic being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating the drug in healthy adult subjects. The drug is being developed by Teva Pharmaceutical Industries Limited.

Who makes Cefadroxil?

Cefadroxil is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development.

What phase is Cefadroxil in?

Cefadroxil is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved for any indication.

What clinical trials is Cefadroxil in?

Cefadroxil has two completed Phase 1 trials: NCT00834275, a study of Cefadroxil 500 mg capsules under fasting conditions, and NCT00835081, a study in normal healthy non-smoking male and female subjects. Each trial enrolled 26 participants.

Is Cefadroxil the same as Cefadroxil 500 mg capsules?

Cefadroxil 500 mg capsules is the formulation used in the clinical trials of Cefadroxil. The trials NCT00834275 and NCT00835081 both evaluated this specific dosage form in healthy volunteers.