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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01389609 | Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition | PHASE1 | COMPLETED | 24 | — | — | Jul 1, 2011 | Aug 1, 2011 | Jan 29, 2021 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions |
| B | EXPERIMENTAL | Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions |
| C | EXPERIMENTAL | Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions |
| Name | Type | Description |
|---|---|---|
| Doxazosin 4 mg Japanese marketed IR tablet | DRUG | Immediate release tablet, 4 mg, single dose |
| Doxazosin 4 mg ODT with water | DRUG | Orally-disintegrating Tablet , 4 mg, single dose with water |
| Doxazosin 4 mg ODT without water | DRUG | Orally-disintegrating Tablet , 4 mg, single dose without water |
Inclusion Criteria: * Japanese healthy male subjects Exclusion Criteria: * Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in SBP, a ≥10 mm Hg reduction in DBP and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supin...