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NCT01634789 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01634789
Other study ID # B2311014
Secondary ID 3115B1-1146
Status Terminated
Phase Phase 1
First received July 3, 2012
Last updated January 17, 2013
Start date August 2012
Est. completion date November 2012

Study information
Verified date January 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• bazedoxifene
20 mg oral tablet, single dose
• bazedoxifene
20 mg oral tablet, single dose
• bazedoxifene
20 mg oral tablet, single dose
• bazedoxifene/conjugated estrogens
20 mg / 0.625 mg oral tablet, single dose

Locations
Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary Relative Bioavailability (F) 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose No
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