Study Evaluating Premarin and Bazedoxifene Potential Interaction
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Premarin (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution,
breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet
when administered together with multiple doses of Premarin (conjugated estrogens or CE) to
healthy postmenopausal women.
Information will also be obtained regarding the safety and tolerability of this combination
in healthy, postmenopausal women.
Clinical Details
Official title: An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.
Study design: Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
Secondary outcome: To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- For inclusion into the study, women must be healthy and postmenopausal (either
naturally or surgically) between the ages of 35 and 70, inclusive.
- Blood hormone levels must be consistent with a postmenopausal state (for specified
subjects).
- They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able
to abstain from smoking during clinic confinements
Exclusion Criteria:
- A subject will be excluded from participation if they :
- Have participated in a clinical drug study within 30 days prior to study medication
administration;
- Have a history of drug or alcohol abuse within 1 year or 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);
- Donate any other plasma or blood during the total study.
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Dr. David Carter, Austin, Texas 78752, United States
Additional Information
Starting date: September 2008
Ending date: October 2008
Last updated: September 29, 2008
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