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Augmentin ES-600

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Augmentin ES-600 · 2 trials · 1 indication

Phase 1 2
NCT00840099600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting ConditionsHealthy
COMPLETED48 Analytics
NCT00840840600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed ConditionsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence Based on Cmax for Amoxicillin
Blood samples collected over 14 hour period

Cmax - Maximum Observed Concentration

Bioequivalence Based on AUC0-inf for Amoxicillin
Blood samples collected over 14 hour period

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)

Bioequivalence Based on AUC0-t for Amoxicillin
Blood samples collected over 14 hour period

AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration

Bioequivalence Based on Cmax for Clavulanic Acid
Blood samples collected over 14 hour period

Cmax - Maximum Observed Concentration

Bioequivalence Based on AUC0-inf for Clavulanic Acid
Blood samples collected over 14 hour period

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)

Bioequivalence Based on AUC0-t for Clavulanic Acid
Blood samples collected over 14 hour period

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mLDRUG1 x 600 mg/42.9 mg/5 mL, single-dose fed
Augmentin ES-600™ 600 mg/42.9 mg/5 mL SuspensionDRUG1 x 600 mg/42.9 mg/5 mL, single-dose fed
Augmentin ES-600™DRUG1 x 600 mg/42.9 mg/5 mL, single-dose fasting
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Eligibility Criteria

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

Inclusion Criteria: * Healthy, non-smoking male or non-pregnant, non-lactating female subjects, 18 years of age and over. * Body weight within ±15% of the appropriate weight range published in 1993 by Metropolitan Life Insurance Company, Statistical Bureau and body-mass index (BMI) less than 30. * ...

Countries:Canada
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Frequently asked questions about Augmentin ES-600

What is Augmentin ES-600?

Augmentin ES-600 is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is a suspension formulation containing 600 mg amoxicillin and 42.9 mg clavulanate potassium per 5 mL. It is currently in Phase 1 clinical development for use in healthy volunteers.

What is Augmentin ES-600 used for?

Augmentin ES-600 is being studied in healthy volunteers as part of Phase 1 clinical trials. The trials are designed to evaluate the drug under fasting and fed conditions. No specific disease indication has been reported for this drug in the available clinical trial data.

Who makes Augmentin ES-600?

Augmentin ES-600 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials for this drug in healthy volunteers.

What phase is Augmentin ES-600 in?

Augmentin ES-600 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, and the drug is not currently in active clinical trials.

What clinical trials is Augmentin ES-600 in?

Augmentin ES-600 has been studied in two completed Phase 1 clinical trials: NCT00840099, which evaluated the drug under fasting conditions, and NCT00840840, which evaluated it under fed conditions. Both trials enrolled 48 healthy volunteers each in Canada, with participants aged 18 years and older.

Is Augmentin ES-600 the same as amoxicillin/clavulanate?

Augmentin ES-600 is a specific formulation of amoxicillin and clavulanate potassium, containing 600 mg amoxicillin and 42.9 mg clavulanate potassium per 5 mL suspension. It is being studied as a distinct product by Teva Pharmaceutical Industries Limited in Phase 1 trials.