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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: bazedoxifene; Drug: bazedoxifene/conjugated estrogens

• Registration Number: NCT01634789
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Study Start: 2012-08
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

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Exclusion Criteria

• Pregnant or nursing females; females of childbearing potential

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Treatment 1: bazedoxifene	bazedoxifene	Test Treatment 1
Reference Treatment: bazedoxifene/conjugated estrogens	bazedoxifene/conjugated estrogens	Reference Treatment
Test Treatment 2: bazedoxifene	bazedoxifene	Test Treatment 2
Test Treatment 3: bazedoxifene	bazedoxifene	Test Treatment 3

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States