Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Bazedoxifene/conjugated estrogens combination (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
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.
Clinical Details
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
Study design: Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: PK parameters
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Gainesville, Florida 32608, United States
Additional Information
Starting date: March 2007
Ending date: April 2007
Last updated: December 19, 2007
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