Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women (CE/BZA)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CE/BZA; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100553

B2311065

Details and patient eligibility

About

This study will assess if itraconazole will affect the blood levels of Duavee when they are given together. This study will also assess if a subject's body size affects the blood levels of Duavee.

Enrollment: 24 patients

Sex: Female

Ages: 40 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy postmenopausal women, aged 40-64. Intact Uterus

Exclusion criteria

• The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Non-Obese

Other group

Description:

BMI \<30 kg/m\^2

Treatment:

Drug: CE/BZA

Drug: Itraconazole

Drug: Itraconazole

Drug: CE/BZA

Drug: CE/BZA

Drug: CE/BZA

Obese

Other group

Description:

BMI \>= 30 kg/m\^2

Treatment:

Drug: CE/BZA

Drug: Itraconazole

Drug: Itraconazole

Drug: CE/BZA

Drug: CE/BZA

Drug: CE/BZA