A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women

Study Overview
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Brief Summary
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The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.

Official Title
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A Phase 1, Open-label, Single-dose, Randomized, 4-treatment, 4- Period, Crossover, Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene (Bza) Compared With A Reference Tablet Formulation of Bza/Conjugated Estrogens (ce) in Healthy Postmenopausal Women

Conditions
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Healthy

Intervention / Treatment
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* Drug: bazedoxifene
* Drug: bazedoxifene
* Drug: bazedoxifene
* Drug: bazedoxifene/conjugated estrogens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy postmenopausal women Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight >= 50 kg Exclusion Criteria: Pregnant or nursing females; females of childbearing potential

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Treatment 1: bazedoxifene<br>Test Treatment 1 | Drug: bazedoxifene<br>* 20 mg oral tablet, single dose<br>* Other names: TSE-424;|
| Experimental: Test Treatment 2: bazedoxifene<br>Test Treatment 2 | Drug: bazedoxifene<br>* 20 mg oral tablet, single dose<br>* Other names: TSE-424;|
| Experimental: Test Treatment 3: bazedoxifene<br>Test Treatment 3 | Drug: bazedoxifene<br>* 20 mg oral tablet, single dose<br>* Other names: TSE-424;|
| Experimental: Reference Treatment: bazedoxifene/conjugated estrogens<br>Reference Treatment | Drug: bazedoxifene/conjugated estrogens<br>* 20 mg / 0.625 mg oral tablet, single dose<br>* Other names: BZA/CE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioavailability