Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00465075
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 23.6

Study Details

Study Description

Brief Summary

The primary objective is to determine the effect of a high-fat meal on the bioavailability and PK of a single, oral dose of BZA/CE (PNP) 20mg/0.625 strength tablet, assessing both the BZA and CE components.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Bazedoxifene/conjugated estrogens combination	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: An Open-Label, Single-Dose, 3-Period, Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of Bazedoxifene Acetate/Conjugated Estrogens (Premarin© New Process) Administered Orally To Healthy, Postmenopausal Women
• Study Start Date: Mar 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. PK parameters []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy as determined by the investigator on the basis of history, physical examinations, clinical laboratory test results, vital signs, and 12-lead ECGs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Gainesville	Florida	United States	32608

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.

• ClinicalTrials.gov Identifier: NCT00465075
• Other Study ID Numbers: 3115A1-1116
• First Posted: Apr 24, 2007
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Dec 28, 2007