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| ID | Type | Description | Link |
|---|---|---|---|
| 3115B1-1146 |
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This study was terminated on 10 December 2012 due to low enrollment. The decision to terminate the study was not based on safety or efficacy issues.
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The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Treatment 1: bazedoxifene | Experimental | Test Treatment 1 |
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| Test Treatment 2: bazedoxifene | Experimental | Test Treatment 2 |
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| Test Treatment 3: bazedoxifene | Experimental | Test Treatment 3 |
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| Reference Treatment: bazedoxifene/conjugated estrogens | Experimental | Reference Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bazedoxifene | Drug | 20 mg oral tablet, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose | |
| Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT) | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose | |
| Time of Maximum Plasma Concentration (Tmax) | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose |
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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 | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| bazedoxifene | Drug | 20 mg oral tablet, single dose |
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| bazedoxifene | Drug | 20 mg oral tablet, single dose |
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| bazedoxifene/conjugated estrogens | Drug | 20 mg / 0.625 mg oral tablet, single dose |
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| Elimination-phase Half-life (t1/2) | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose |
| Relative Bioavailability (F) | 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose |
| ID | Term |
|---|---|
| C447119 | bazedoxifene |
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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