Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Augmentin · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Amoxicillin Clavulanic Acid | EXPERIMENTAL | Amoxicillin 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_COMPARATOR | Augmentin® 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 Acid | EXPERIMENTAL | Amoxicillin 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 |
| Name | Type | Description |
|---|---|---|
| amoxicillin-clavulanic acid | DRUG | 400 mg-57 mg chewable tablet |
| Augmentin® | DRUG | 400 mg-57 mg chewable tablet |
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...
Augmentin is an investigational small molecule being studied in healthy volunteers. It is a combination of amoxicillin and clavulanic acid, and the ongoing clinical development focuses on pharmacokinetic studies of chewable tablets under fasting and non-fasting conditions. It is not approved for any disease indication.
Augmentin is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetic profile in healthy subjects.
Augmentin 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, both involving healthy volunteers.
Augmentin has been studied in two completed Phase 1 trials: NCT00835705, which evaluated amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets under fasting conditions, and NCT00836901, which evaluated the same tablets under non-fasting conditions. Both trials enrolled 52 healthy participants in Canada.
Yes, Augmentin is the brand name for the combination of amoxicillin and clavulanic acid. The clinical trials listed under the name Augmentin specifically test amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets.