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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT01634789

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: bazedoxifene Drug: bazedoxifene Drug: bazedoxifene Drug: bazedoxifene/conjugated estrogens	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Open-label, Single-dose, Randomized, 4-treatment, 4- Period, Crossover, Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene (Bza) Compared With A Reference Tablet Formulation of Bza/Conjugated Estrogens (ce) in Healthy Postmenopausal Women

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Treatment 1: bazedoxifene Test Treatment 1	Drug: bazedoxifene 20 mg oral tablet, single dose Other Names: TSE-424
Experimental: Test Treatment 2: bazedoxifene Test Treatment 2	Drug: bazedoxifene 20 mg oral tablet, single dose Other Names: TSE-424
Experimental: Test Treatment 3: bazedoxifene Test Treatment 3	Drug: bazedoxifene 20 mg oral tablet, single dose Other Names: TSE-424
Experimental: Reference Treatment: bazedoxifene/conjugated estrogens Reference Treatment	Drug: bazedoxifene/conjugated estrogens 20 mg / 0.625 mg oral tablet, single dose Other Names: BZA/CE

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) [0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose]
Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT) [0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose]

Secondary Outcome Measures

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) [0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose]
Time of Maximum Plasma Concentration (Tmax) [0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose]
Elimination-phase Half-life (t1/2) [0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose]
Relative Bioavailability (F) [0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01634789

Other Study ID Numbers:

B2311014
3115B1-1146

First Posted:

Jul 6, 2012

Last Update Posted:

Jan 18, 2013

Last Verified:

Jan 1, 2013

Keywords provided by Pfizer

bioavailability

Additional relevant MeSH terms:

Bazedoxifene

Estrogens

Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Jan 18, 2013