Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lotrel · 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...
Lotrel is an investigational small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and it is not yet approved by the FDA.
Lotrel is being studied for use in healthy subjects. The ongoing clinical trials are evaluating the drug in healthy volunteers under fasting and fed conditions. It is not yet approved for any specific medical condition.
Lotrel is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. Teva is conducting clinical trials to evaluate the drug's effects in healthy subjects.
Lotrel is in Phase 1 clinical development. There are two completed Phase 1 trials, with a total of 116 participants enrolled. The drug is still investigational and has not been approved by regulatory authorities.
Lotrel has been studied in two completed Phase 1 clinical trials: NCT00834977, which evaluated the drug in healthy subjects under fasting conditions, and NCT00835367, which evaluated it under fed conditions. Both trials were conducted in Canada.
Yes, Lotrel is the same as amlodipine-benazepril. The clinical trials for Lotrel are titled 'Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects,' indicating that Lotrel is a combination of amlodipine and benazepril.