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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00841542 | Amlodipine 10 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2003 | May 1, 2003 | Aug 20, 2024 | 1 | Canada |
| NCT00841815 | Amlodipine 10 mg Tablets Under Fed Conditions | PHASE1 | COMPLETED | 28 | — | — | Apr 1, 2003 | May 1, 2003 | Aug 20, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Amlodipine Besylate | EXPERIMENTAL | Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period |
| Norvasc® | ACTIVE_COMPARATOR | Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Amlodipine Besylate | DRUG | 10 mg Tablet |
| Norvasc® | DRUG | 10 mg Tablet |
Inclusion Criteria * Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening). * Body Mass Index (BMI = weight/height2) greater than or equal to 19.0 kg.m2 and less than or equal to 30.0 kg/m2. * Normal...