Status:
COMPLETED
Study Evaluating Premarin and Bazedoxifene Potential Interaction
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
Brief 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 to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00745173
Start Date
September 1 2008
End Date
October 1 2008
Last Update
February 12 2009
Active Locations (1)
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1
Dr. David Carter
Austin, Texas, United States, 78752