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To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxazosin 4 mg Japanese marketed IR tablet | Drug | Immediate release tablet, 4 mg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) and AUC from zero to the last sampling point (AUCt) of doxazosin 4 mg Orally Disintegrating Tablet (ODT) without water compared to doxazosin 4 mg Japanese marketed Immediate Release (IR) tablet under fasted conditions | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUCt of doxazosin 4 mg ODT with water compared to doxazosin 4 mg Japanese marketed IR tablet under fasted conditions. | up to 48 hours | |
| Other Pharmacokinetic (PK) parameters (Tmax, AUC from zero to infinity (AUCinf), AUC from zero to the last measurable point (AUClast), elimination rate constant (Kel), t½, and mean residence time (MRT) of doxazosin under all forms of |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
|
| up to 48 hours |
| administration. | up to 48 hours |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017292 | Doxazosin |
| D014867 | Water |
| ID | Term |
|---|---|
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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