A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women

NCT ID: NCT01634789

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Test Treatment 1: bazedoxifene

Test Treatment 1

Group Type EXPERIMENTAL

bazedoxifene

Intervention Type DRUG

20 mg oral tablet, single dose

Test Treatment 2: bazedoxifene

Test Treatment 2

Group Type EXPERIMENTAL

bazedoxifene

Intervention Type DRUG

20 mg oral tablet, single dose

Test Treatment 3: bazedoxifene

Test Treatment 3

Group Type EXPERIMENTAL

bazedoxifene

Intervention Type DRUG

20 mg oral tablet, single dose

Reference Treatment: bazedoxifene/conjugated estrogens

Reference Treatment

Group Type EXPERIMENTAL

bazedoxifene/conjugated estrogens

Intervention Type DRUG

20 mg / 0.625 mg oral tablet, single dose

Interventions

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bazedoxifene

20 mg oral tablet, single dose

Intervention Type DRUG

bazedoxifene

20 mg oral tablet, single dose

Intervention Type DRUG

bazedoxifene

20 mg oral tablet, single dose

Intervention Type DRUG

bazedoxifene/conjugated estrogens

20 mg / 0.625 mg oral tablet, single dose

Intervention Type DRUG

Other Intervention Names

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TSE-424 TSE-424 TSE-424 BZA/CE

Eligibility Criteria

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Inclusion Criteria

* Generally healthy postmenopausal women
* Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight \>= 50 kg

Exclusion Criteria

* Pregnant or nursing females; females of childbearing potential
Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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3115B1-1146

Identifier Type: -

Identifier Source: secondary_id

B2311014

Identifier Type: -

Identifier Source: org_study_id

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