Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Augmentin ES-600 · 2 trials · 1 indication
Cmax - Maximum Observed Concentration
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration
Cmax - Maximum Observed Concentration
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL | DRUG | 1 x 600 mg/42.9 mg/5 mL, single-dose fed |
| Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension | DRUG | 1 x 600 mg/42.9 mg/5 mL, single-dose fed |
| Augmentin ES-600™ | DRUG | 1 x 600 mg/42.9 mg/5 mL, single-dose fasting |
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. * ...
Augmentin ES-600 is a small molecule anti-infective developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It is an oral suspension formulation containing 600 mg amoxicillin and 42.9 mg clavulanate potassium per 5 mL. It has been studied in Phase 1 clinical trials involving healthy adult volunteers.
Augmentin ES-600 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials conducted for this product.
Augmentin ES-600 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with no active trials currently listed. The studies enrolled a total of 96 participants and were conducted in Canada.
Augmentin ES-600 has been evaluated in two completed Phase 1 trials: NCT00840840, which studied the suspension under fed conditions, and NCT00840099, which studied it under fasting conditions. Both enrolled 48 healthy adult volunteers in Canada and were active-controlled, randomized studies.