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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01634789

Enrollment

Registered

2012-07-06

Start date

2012-08-31

Completion date

2012-11-30

Last updated

2013-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

bioavailability

Brief summary

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

Interventions

DRUGbazedoxifene/conjugated estrogens

20 mg / 0.625 mg oral tablet, single dose

DRUGbazedoxifene

20 mg oral tablet, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026