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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01436513 | A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. | PHASE1 | COMPLETED | 72 | — | — | Oct 1, 2011 | Mar 1, 2012 | Mar 15, 2012 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Premarin reference tablet as a single oral dose under fasted conditions |
| B | EXPERIMENTAL | Premarin new tablet as a single oral dose under fasted conditions |
| C | EXPERIMENTAL | Premarin reference tablet as a single oral dose under fed conditions |
| D | EXPERIMENTAL | Premarin new tablet as a single oral dose under fed conditions |
| Name | Type | Description |
|---|---|---|
| Premarin reference tablet (fasted) | DRUG | Premarin reference tablet, single dose, fasted conditions |
| Premarin new tablet (fasted) | DRUG | Premarin new tablet, single dose, fasted conditions |
| Premarin reference tablet (fed) | DRUG | Premarin reference tablet, single dose, fed conditions |
| Premarin new tablet (fed) | DRUG | Premarin new tablet, single dose, fed conditions |
Inclusion Criteria: * Japanese healthy postmenopausal women Exclusion Criteria: * History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies. * History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malign...