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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01124162 | Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 80 | — | — | Oct 1, 2003 | Nov 1, 2003 | Dec 8, 2010 | 1 | Canada |
| NCT01124175 | Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions | PHASE1 | COMPLETED | 80 | — | — | Oct 1, 2003 | Nov 1, 2003 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Losartan Cmax.
Bioequivalence based on Losartan AUC0-t.
Bioequivalence based on Losartan AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Generic Test Product | EXPERIMENTAL | Losartan 100mg Tablets |
| Reference Listed Drug | ACTIVE_COMPARATOR | Cozaar® 100 mg Tablets |
| Name | Type | Description |
|---|---|---|
| Losartan | DRUG | 100 mg Tablet |
| Cozaar® | DRUG | 100 mg Tablet |
Inclusion Criteria: * Non-child-bearing potential female or male. * Non-smoker. * 18 years of age and older. * Capable of consent. * Non-child-bearing potential female subject: * Post-menopausal state: absence of menses for 12 months prior to drug administration. * Surgically sterile: hysterec...