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...
Amlodipine-benazepril is a small molecule combination product developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It combines amlodipine and benazepril and has been studied in Phase 1 clinical trials. The specific therapeutic indication for this formulation has not been disclosed.
Amlodipine-benazepril is made by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the developer of the amlodipine-benazepril 10 mg-20 mg capsules that have been evaluated in clinical studies.
Amlodipine-benazepril is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Amlodipine-benazepril has been studied in two completed Phase 1 trials: NCT00835367, which evaluated the 10 mg-20 mg capsules in healthy subjects under fed conditions with 68 participants, and NCT00834977, which tested the same capsules under fasting conditions with 48 participants. Both trials were conducted in Canada.