Study Evaluating Bazedoxifene/CE in Postmenopausal Women
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 (Device)
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 this clinical trial is to study the blood levels of a drug (conjugated
estrogens) in the body from one dosage form compared to another. The four formulations of the
study drug that eligible participants will receive will contain the same amounts of the same
medications. In addition, information will also be obtained regarding the safety and
tolerability of the formulations given to healthy postmenopausal women.
Clinical Details
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Primary outcome: The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women aged 35 to 70 years.
- Spontaneous or surgical amenorrhea for at least 6 months.
- Body mass index (BMI) in the range of 18. 0 to 35. 0 kg/m2 and body weight greater than
or equal to 50 kg.
Exclusion Criteria:
- Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg
diastolic).
- History of any clinically important drug allergy.
- Use of any prescription or investigational drug within 30 days before test article
administration.
Locations and Contacts
Additional Information
Starting date: September 2007
Ending date: November 2007
Last updated: January 11, 2008
|
