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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

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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Contact
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.
Show details

- 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.
Show details

- Pregnant or nursing females; females of childbearing potential

NCT01634789
Pfizer
Terminated
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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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
The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
45 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01634789
B2311014
3115B1-1146
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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