Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00840099 | 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions | PHASE1 | COMPLETED | 48 | — | — | Aug 1, 2002 | Aug 1, 2002 | Aug 20, 2024 | 1 | Canada |
| NCT00840840 | 600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions | PHASE1 | COMPLETED | 48 | — | — | Aug 1, 2002 | Aug 1, 2002 | Aug 20, 2024 | 1 | Canada |
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. * ...