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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834977 | Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 48 | — | — | Apr 1, 2004 | May 1, 2004 | Sep 19, 2024 | 2 | Canada |
| NCT00835367 | Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions | PHASE1 | COMPLETED | 68 | — | — | Mar 1, 2004 | Mar 1, 2004 | Aug 21, 2024 | 2 | Canada |
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...