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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00465075

Enrollment

Registered

2007-04-24

Start date

2007-03-31

Completion date

2007-04-30

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBazedoxifene/conjugated estrogens combination

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
PK parameters	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026