Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amlodipine-benazepril · 2 trials · 1 indication
Bioequivalence based on Cmax - Maximum observed concentration
Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
Bioequvialence based on Cmax - Maximum observed concentration
Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
| Arm | Type | Description |
|---|---|---|
| Amlodipine Benazepril | EXPERIMENTAL | Amlodipine Benazepril 10mg-20mg Capsule (test) dosed in first period followed by Lotrel® 10mg-20mg Capsule (reference) dosed in second period |
| Lotrel® | ACTIVE_COMPARATOR | Lotrel® 10mg-20mg Capsule (reference) dosed in first period followed by Amlodipine Benazepril 10mg-20mg Capsules (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Amlodipine-benazepril 10 mg-20 mg capsules | DRUG | 1 x 10-20 mg |
| Lotrel® 10 mg-20 mg capsule | DRUG | 1 x 10-20 mg |
Inclusion Criteria: * Male of non-child-bearing potential female, non-smoker, 18 years of age and older. * Non-child-bearing potential female subjects is defined as follows: * Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy woth bilateral oophorec...