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

This study has been completed.

First Received: April 23, 2007 Last Updated: December 19, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00465075

Purpose

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	Intervention	Phase
Healthy	Drug: Bazedoxifene/conjugated estrogens combination	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

PK parameters

Estimated Enrollment:	24
Study Start Date:	March 2007
Study Completion Date:	April 2007

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465075

Locations

United States, Florida

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3115A1-1116
Study First Received:	April 23, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00465075 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010