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

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NCT01634789

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Pregnant or nursing females; females of childbearing potential

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: bazedoxifene
    20 mg oral tablet, single dose
    Other Name: TSE-424
  • Drug: bazedoxifene/conjugated estrogens
    20 mg / 0.625 mg oral tablet, single dose
    Other Name: BZA/CE
Study Arms  ICMJE
  • Experimental: Test Treatment 1: bazedoxifene
    Test Treatment 1
    Intervention: Drug: bazedoxifene
  • Experimental: Test Treatment 2: bazedoxifene
    Test Treatment 2
    Intervention: Drug: bazedoxifene
  • Experimental: Test Treatment 3: bazedoxifene
    Test Treatment 3
    Intervention: Drug: bazedoxifene
  • Experimental: Reference Treatment: bazedoxifene/conjugated estrogens
    Reference Treatment
    Intervention: Drug: bazedoxifene/conjugated estrogens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)		2
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)		30
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01634789
Other Study ID Numbers  ICMJE B2311014
3115B1-1146
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP