Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopause
Intervention: Bazedoxifene/conjugated estrogens (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is
given in combination with 2 different formulations of conjugated estrogens. It is an open
label study with no placebo control or comparator drugs. Subjects will take one dose of the
investigation formulation daily for 14 days.
Clinical Details
Official title: An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic analyses.
Eligibility
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
- Postmenopausal women, aged 40 to 65 years.
- Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products
within 8 weeks before screening.
- A history or active presence of clinically relevant important medical disease.
Locations and Contacts
Gainesville, Florida 32608, United States
Additional Information
Starting date: April 2007
Ending date: July 2007
Last updated: December 19, 2007
|
