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...
Date First Received: April 23, 2007
Last Updated: December 19, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 1 | Start Date: March 2007
Overall Status: Completed
Estimated Enrollment: 24
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: Bazedoxifene/conjugated estrogens combination
Outcome Measures for this Clinical Trial
Primary Measures
- PK parameters
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 35 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 July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00465075
Study ID Number: 3115A1-1116
ClinicalTrials.gov Identifier: NCT00465075
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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