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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
SeaView Research, Inc. (Screening Office)
Miami, Florida, 33125 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT02100553
Pfizer
Completed
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

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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
A Phase 1, Open Label, Two Period, Fixed Sequence, Parallel Group Study To Estimate The Effects Of Multiple Dose Administration Of Itraconazole On The Single Dose Pharmacokinetics Of Conjugated Estrogens/Bazedoxifene In Non Obese (Bmi <30 Kg/m2) And Obese (Bmi ?30 Kg/m2) Postmenopausal Women
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: CE/BZA
    CE 0.45mg/BZA 20mg tablets, single dose
    Other Name: Duavee
  • Drug: Itraconazole
    Two 100 mg capsules, once daily for 7 days
    Other Name: Sporanox
  • Drug: CE/BZA
    CE 0.45mg/BZA 20mg tablets, single dose on Day 5
    Other Name: Duavee
  • Non-Obese
    BMI <30 kg/m^2
    Interventions:
    • Drug: CE/BZA
    • Drug: Itraconazole
    • Drug: CE/BZA
  • Obese
    BMI >= 30 kg/m^2
    Interventions:
    • Drug: CE/BZA
    • Drug: Itraconazole
    • Drug: CE/BZA
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
40 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02100553
B2311065
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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