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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

This study has been terminated.
(This study was terminated on 10 December 2012 due to low enrollment. The decision to terminate the study was not based on safety or efficacy issues.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01634789
First received: July 3, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: bazedoxifene
Drug: bazedoxifene/conjugated estrogens
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Time of Maximum Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Elimination-phase Half-life (t1/2) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Relative Bioavailability (F) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Treatment 1: bazedoxifene
Test Treatment 1
 Drug: bazedoxifene
20 mg oral tablet, single dose
Other Name: TSE-424
Experimental: Test Treatment 2: bazedoxifene
Test Treatment 2
 Drug: bazedoxifene
20 mg oral tablet, single dose
Other Name: TSE-424
Experimental: Test Treatment 3: bazedoxifene
Test Treatment 3
 Drug: bazedoxifene
20 mg oral tablet, single dose
Other Name: TSE-424
Experimental: Reference Treatment: bazedoxifene/conjugated estrogens
Reference Treatment
 Drug: bazedoxifene/conjugated estrogens
20 mg / 0.625 mg oral tablet, single dose
Other Name: BZA/CE

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634789

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01634789     History of Changes
Other Study ID Numbers: B2311014, 3115B1-1146
Study First Received: July 3, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
bioavailability

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 June 18, 2013