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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

NCT02100553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

CE/BZA

CE 0.45mg/BZA 20mg tablets, single dose

DRUG

Itraconazole

Two 100 mg capsules, once daily for 7 days

DRUG

CE/BZA

CE 0.45mg/BZA 20mg tablets, single dose on Day 5

DRUG

CE/BZA

CE 0.45mg/BZA 20mg tablets, single dose

DRUG

Itraconazole

Two 100 mg capsules, once daily for 7 days

DRUG

CE/BZA

CE 0.45mg/BZA 20mg tablets, single dose on Day 5

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100553 on ClinicalTrials.gov