Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
amoxicillin-clavulanic acid · 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...
Amoxicillin-clavulanic acid is a small molecule combination product developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It combines amoxicillin with clavulanic acid. The specific therapeutic indication for this Teva product is undisclosed, and the program is in Phase 1 clinical development.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of this amoxicillin-clavulanic acid product. Teva is the sponsor of the clinical trials evaluating the drug.
Amoxicillin-clavulanic acid is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program has not been approved by the FDA for the undisclosed indication being studied.
Two completed Phase 1 trials have evaluated amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets. NCT00836901 studied the tablets under non-fasting conditions, and NCT00835705 studied them under fasting conditions. Both enrolled 52 healthy adult volunteers in Canada, for a total enrollment of 104 participants.
Both Phase 1 trials of amoxicillin-clavulanic acid were randomized, active-controlled studies in healthy volunteers aged 18 years and older. The trials were not double-blind. NCT00836901 evaluated the chewable tablets under non-fasting conditions, and NCT00835705 evaluated them under fasting conditions.