Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
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 combination tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also
called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).
About 24 subjects will take part in this study. Each subject's participation in this study
will last for about 10 weeks. During this study, each subject will receive 3 different types
of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to
learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA
oral solution. In addition, information will also be learned about the safety and
tolerability of these dosage forms given to healthy postmenopausal women.
Clinical Details
Official title: An Open-Label, Single-Dose, Randomized-to-Sequence, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.
Study design: Screening, Longitudinal, Defined Population, Prospective Study
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
postmenopausal women aged 35 to 70 years.
- At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea
with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL. Women 55 years of
older must have at least 12 months of amenorrhea
- Body mass index in the range of 18. 0 to 35. 0, with a minimum body weight of 50 kg.
Exclusion Criteria:
- A history or active presence of clinically important medical disease.
- History or alcoholism or drug abuse within 1 year before study start.
- Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of
administration within 6 months before study day 1 must be approved by Wyeth Research.
Locations and Contacts
Additional Information
Starting date: August 2006
Ending date: August 2006
Last updated: March 12, 2007
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