Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
NCT ID: NCT00706225
Last Updated: 2010-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2008-06-30
2008-07-31
Brief Summary
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PREMARIN® (conjugated estrogens \[CE\]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.
Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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1
Bazedoxifene and Conjugated Estrogens (BZA \& CE)
Bazedoxifene and conjugated estrogens
Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Interventions
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Bazedoxifene and conjugated estrogens
Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Eligibility Criteria
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Inclusion Criteria
* Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
* Must not have a history of drug or alcohol abuse within 1 year and do not consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine)
* Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
* Must not donate any other plasma or blood during the total study.
* All test results and study criteria for the study are met.
Exclusion Criteria
* Health assessed by clinical chemistry laboratory results and physical exam.
35 Years
70 Years
FEMALE
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Daytona Beach, Florida, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3115A1-1134
Identifier Type: -
Identifier Source: org_study_id