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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02594761 | Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion | PHASE1 | COMPLETED | 132 | — | — | Aug 1, 2013 | Feb 1, 2014 | Nov 3, 2015 | - | — |
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized Cmax based on the equivalence criterion that Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-last based on the equivalence criterion that AUC0-last least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-∞, based on the equivalence criterion that AUC0-∞ least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Hercules: 8 mg/kg i.v. infusion over 90 minutes |
| Treatment B | ACTIVE_COMPARATOR | Herceptin EU: 8 mg/kg i.v. infusion over 90 minutes |
| Treatment C | ACTIVE_COMPARATOR | Herceptin US: 8 mg/kg i.v. infusion over 90 minutes |
| Name | Type | Description |
|---|---|---|
| Hercules | BIOLOGICAL | Powder Concentrate for Intravenous Infusion, 150 mg/vial |
| Herceptin EU | BIOLOGICAL | Powder for Concentrate for Solution for Infusion, 150 mg/vial |
| Herceptin US | BIOLOGICAL | Intravenous Infusion, 440 mg/vial |
Inclusion Criteria: * healthy adult subjects, age 18 to 55 years old * able to understand procedures, agree to participate and willing to give informed consent Exclusion Criteria: * history of any significant disease * use of any medication 7 days prior to start of study * participation in a clin...