Study Stopped
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.
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
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
2 other identifiers
interventional
2
1 country
1
Brief Summary
The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 18, 2013
January 1, 2013
3 months
July 3, 2012
January 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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
Study Arms (4)
Test Treatment 1: bazedoxifene
EXPERIMENTALTest Treatment 1
Test Treatment 2: bazedoxifene
EXPERIMENTALTest Treatment 2
Test Treatment 3: bazedoxifene
EXPERIMENTALTest Treatment 3
Reference Treatment: bazedoxifene/conjugated estrogens
EXPERIMENTALReference Treatment
Interventions
20 mg / 0.625 mg oral tablet, single dose
Eligibility Criteria
You may qualify if:
- Generally healthy postmenopausal women
- Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight \>= 50 kg
You may not qualify if:
- Pregnant or nursing females; females of childbearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2012
First Posted
July 6, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
January 18, 2013
Record last verified: 2013-01