Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms

Wyeth

Status and phase: Completed; Phase 1

Conditions: Postmenopause

Treatments: Drug: Bazedoxifene/conjugated estrogens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479778

3115A1-1121

Details and patient eligibility

About

The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Postmenopausal women, aged 40 to 65 years.
• Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.
• A history or active presence of clinically relevant important medical disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)