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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women

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NCT00465075

Last updated on October 5, 2018
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Study Location
Gainesville, Florida, 32608 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
35-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy as determined by the investigator on the basis of history, physical
examinations, clinical laboratory test results, vital signs, and 12-lead ECGs.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Healthy as determined by the investigator on the basis of history, physical
examinations, clinical laboratory test results, vital signs, and 12-lead ECGs.

NCT00465075
Pfizer
Completed
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women

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Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women
An Open-Label, Single-Dose, 3-Period, Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of Bazedoxifene Acetate/Conjugated Estrogens (Premarin© New Process) Administered Orally To Healthy, Postmenopausal Women
The primary objective is to determine the effect of a high-fat meal on the bioavailability and PK of a single, oral dose of BZA/CE (PNP) 20mg/0.625 strength tablet, assessing both the BZA and CE components.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Healthy
Drug: Bazedoxifene/conjugated estrogens combination
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2007
Not Provided

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of history, physical examinations, clinical laboratory test results, vital signs, and 12-lead ECGs.
Sexes Eligible for Study: Female
35 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00465075
3115A1-1116
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

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

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1-800-718-1021

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