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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: bazedoxifene/conjugated estrogens; Drug: bazedoxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634789

B2311014

3115B1-1146

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: Female

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 4 patient groups

Test Treatment 1: bazedoxifene

Experimental group

Description:

Test Treatment 1

Treatment:

Drug: bazedoxifene

Drug: bazedoxifene

Drug: bazedoxifene

Test Treatment 2: bazedoxifene

Experimental group

Description:

Test Treatment 2

Treatment:

Drug: bazedoxifene

Drug: bazedoxifene

Drug: bazedoxifene

Test Treatment 3: bazedoxifene

Experimental group

Description:

Test Treatment 3

Treatment:

Drug: bazedoxifene

Drug: bazedoxifene

Drug: bazedoxifene

Reference Treatment: bazedoxifene/conjugated estrogens

Experimental group

Description:

Reference Treatment

Treatment:

Drug: bazedoxifene/conjugated estrogens