NCT00367536

Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postmenopause

Interventions

Type	Name	Description
DRUG	bazedoxifene/conjugated estrogens combination tablet

Timeline

• Start date: 2006-08-01
• Completion: 2006-08-01
• First posted: 2006-08-23
• Last updated: 2015-05-01