Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00550303
Collaborator
(none)
28
1
Study Details
Study Description
Brief Summary
The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
28 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Single-Dose, Non-Randomized, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women
Study Start Date
:
Oct 1, 2007
Actual Study Completion Date
:
Nov 1, 2007
Outcome Measures
Primary Outcome Measures
- Bioavailability []
Secondary Outcome Measures
- Safety & tolerability []
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy, post menopausal women ages 45 to 70
Exclusion Criteria:
- Male subjects
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00550303
Other Study ID Numbers:
- 3115A1-1123
First Posted:
Oct 29, 2007
Last Update Posted:
Dec 27, 2007
Last Verified:
Dec 1, 2007