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TerminatedNCT01634789Updated Jan 18, 2013

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 interventional study of bazedoxifene and bazedoxifene in Healthy, sponsored by Pfizer. Terminated at 1 site in United States. Open to female participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-18.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Why this study was terminated
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.
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • bioavailability
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Pregnant or nursing females; females of childbearing potential
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Test Treatment 1: bazedoxifene

    Test Treatment 1

    Drug: bazedoxifene

  • Experimental
    Test Treatment 2: bazedoxifene

    Test Treatment 2

    Drug: bazedoxifene

  • Experimental
    Test Treatment 3: bazedoxifene

    Test Treatment 3

    Drug: bazedoxifene

  • Experimental
    Reference Treatment: bazedoxifene/conjugated estrogens

    Reference Treatment

    Drug: bazedoxifene/conjugated estrogens

Interventions

  • Drugbazedoxifene

    20 mg oral tablet, single dose

    Also known as: TSE-424

  • Drugbazedoxifene

    20 mg oral tablet, single dose

    Also known as: TSE-424

  • Drugbazedoxifene

    20 mg oral tablet, single dose

    Also known as: TSE-424

  • Drugbazedoxifene/conjugated estrogens

    20 mg / 0.625 mg oral tablet, single dose

    Also known as: BZA/CE

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose

  2. Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT)

    Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose

Secondary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf)

    Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose

  2. Time of Maximum Plasma Concentration (Tmax)

    Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose

  3. Elimination-phase Half-life (t1/2)

    Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose

  4. Relative Bioavailability (F)

    Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose

07

Study locations

1 site
  • Pfizer Investigational Site
    New Haven, Connecticut 06511, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01634789
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jul 6, 2012
Start date
Aug 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Jan 18, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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