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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

NCT ID: NCT02100553

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Non-Obese

BMI \<30 kg/m\^2

Group Type OTHER

CE/BZA

Intervention Type DRUG

CE 0.45mg/BZA 20mg tablets, single dose

Itraconazole

Intervention Type DRUG

Two 100 mg capsules, once daily for 7 days

CE/BZA

Intervention Type DRUG

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

Obese

BMI \>= 30 kg/m\^2

Group Type OTHER

CE/BZA

Intervention Type DRUG

CE 0.45mg/BZA 20mg tablets, single dose

Itraconazole

Intervention Type DRUG

Two 100 mg capsules, once daily for 7 days

CE/BZA

Intervention Type DRUG

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

Interventions

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CE/BZA

CE 0.45mg/BZA 20mg tablets, single dose

Intervention Type DRUG

Itraconazole

Two 100 mg capsules, once daily for 7 days

Intervention Type DRUG

CE/BZA

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

Intervention Type DRUG

CE/BZA

CE 0.45mg/BZA 20mg tablets, single dose

Intervention Type DRUG

Itraconazole

Two 100 mg capsules, once daily for 7 days

Intervention Type DRUG

CE/BZA

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

Intervention Type DRUG

Other Intervention Names

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Duavee Sporanox Duavee Duavee Sporanox Duavee

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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SeaView Research, Inc. (Screening Office)

Miami, Florida, United States

Site Status

SeaView Research, Inc.

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2311065&StudyName=Study%20Evaluating%20Effects%20of%20Multiple-Dose%20Administration%20of%20Itraconazole%20on%20the%20Single%20Dose%20Pharmacokinetics%20of%20Conjugated%20Estrogens/Bazedoxifen

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2311065

Identifier Type: -

Identifier Source: org_study_id

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