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...
Date First Received: October 25, 2007
Last Updated: January 11, 2008
Verified by: Wyeth, January 2008
Clinical Trial Phase: Phase 1 | Start Date: September 2007
Overall Status: Completed
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Intervention(s) in this Clinical Trial
- Device: Bazedoxifene/Conjugated Estrogens
Outcome Measures for this Clinical Trial
Primary Measures
- The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
Criteria for Participation in this Clinical Trial
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.
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 September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00550433
Study ID Number: 3115A1-1117
ClinicalTrials.gov Identifier: NCT00550433
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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