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Augmentin

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00835705Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting ConditionsPHASE1 COMPLETED 52 — — Sep 1, 2003Sep 1, 2003Aug 20, 20241 Canada
NCT00836901Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting ConditionsPHASE1 COMPLETED 52 — — Sep 1, 2003Sep 1, 2003Aug 21, 20241 Canada
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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 — 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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