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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:
ClinicalTrials.gov Identifier:
NCT01634789
First Posted: July 6, 2012
Last Update Posted: January 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
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

Resource links provided by NLM:


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 ]
  • 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01634789     History of Changes
Other Study ID Numbers: B2311014
3115B1-1146
First Submitted: July 3, 2012
First Posted: July 6, 2012
Last Update Posted: January 18, 2013
Last Verified: January 2013

Keywords provided by Pfizer:
bioavailability

Additional relevant MeSH terms:
Estrogens
Estrogens, Conjugated (USP)
Bazedoxifene
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents