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amoxicillin-clavulanic acid

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 21, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

amoxicillin-clavulanic acid · 2 trials · 1 indication

Phase 1 2
NCT00835705Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting ConditionsHealthy
COMPLETED52 Analytics
NCT00836901Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting ConditionsHealthy
COMPLETED52 Analytics
PHASE1COMPLETED
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions
Healthy
NCT0083570552
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PHASE1COMPLETED
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
Healthy
NCT0083690152
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Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration) - Amoxicillin
Blood samples were collected over 10 hour period

Bioequivalence based on Cmax

AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
Blood samples were collected over 10 hour period

Bioequivalence based on AUC0-inf

AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
Blood samples were collected over 10 hour period

Bioequivalence based on AUC0-t

Cmax (Maximum Observed Concentration) - Clavulanic Acid
Blood samples collected over 10 hour period

Bioequivalence based on Cmax

AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid
Blood samples collected over 10 hour period

Bioequivalence based on AUC0-inf

AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid
Blood samples collected over 10 hour period

Bioequivalence based on AUC0-t

AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
Blood samples collected over 10 hour period

Bioequivalence based on AUC0-t

AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid
Blood samples collected over 10 hour period

Bioequivalence based on AUC0-inf

AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid
Blood samples collected over 10 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Amoxicillin Clavulanic AcidEXPERIMENTALAmoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 400-57 mg Chewable Tablet (reference) dosed in second period
Augmentin®ACTIVE_COMPARATORAugmentin® 400-57 mg Chewable Tablet (reference) dosed in first period followed by Amoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in second period
Amoxicillin Calvulanic AcidEXPERIMENTALAmoxicillin Clavulanic Acid 400-57 mg Chewable Tablet (test) dosed in first period followed by Augmentin® 40-57 mg Chewable Tablet (reference) dosed in second period

Interventions

NameTypeDescription
amoxicillin-clavulanic acidDRUG400 mg-57 mg chewable tablet
Augmentin®DRUG400 mg-57 mg chewable tablet
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Eligibility Criteria

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

Inclusion Criteria * Subjects will be females and/or males, non-smokers, 18 years of age and older. Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses within 4 weeks of the administration of study medication. * Cli...

Countries:Canada
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