NCT00465075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

April 23, 2007

Last Update Submit

December 19, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • PK parameters

Interventions

Bazedoxifene/conjugated estrogens combinationDRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

bazedoxifene

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

March 1, 2007

Study Completion

April 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

US(1)