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

This study has been completed.

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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

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

Additional relevant MeSH terms:

Estrogens, Conjugated (USP)
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012