The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes...
Date First Received: October 25, 2007
Last Updated: December 18, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 1 | Start Date: October 2007
Overall Status: Completed
Estimated Enrollment: 28
Brief Summary
Official Title: “An Open-Label, Single-Dose, Non-Randomized, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women”
Condition Keyword(s):
Intervention(s):
The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
Intervention(s) in this Clinical Trial
- Drug: bazedoxifene/conjugated estrogens combination
Outcome Measures for this Clinical Trial
Primary Measures
- Bioavailability
Secondary Measures
- Safety & tolerability
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy, post menopausal women ages 45 to 70
Exclusion Criteria:
- Male subjects
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00550303
Study ID Number: 3115A1-1123
ClinicalTrials.gov Identifier: NCT00550303
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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