Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367536
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2006-08-21
Brief Title:
Study Evaluating Three BazedoxifeneConjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
An Open-label Single-dose Randomized-to-sequence 4-period Crossover Bioavailability Study of Bazedoxifene Contained in BazedoxifeneConjugated Estrogen Tablets Administered to Healthy Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves the experimental drug bazedoxifene acetateconjugated estrogens also called BZACE This drug is not approved by the Food and Drug Administration FDA
About 24 subjects will take part in this study Each subjects participation in this study will last for about 10 weeks During this study each subject will receive 3 different types of BZACE 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
About 24 subjects will take part in this study Each subjects participation in this study will last for about 10 weeks During this study each subject will receive 3 different types of BZACE 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None