Healthy
Conditions
Keywords
Postmenopausal Women, Obese, Non-obese, Drug Interaction with Itraconazole, Pharmacokinetic
Brief 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.
Interventions
DRUGCE/BZA
CE 0.45mg/BZA 20mg tablets, single dose
DRUGItraconazole
Two 100 mg capsules, once daily for 7 days
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin. | up to 96 hours | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). |
| Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin. | up to 96 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Oral Clearance (CL/F) for all analytes. | up to 96 hours | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes. | up to 96 hours | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin. | up to 96 hours | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). |
| Terminal Phase Elimination Half-Life (t1/2) for all analytes. | up to 96 hours | Terminal Phase Elimination Half-Life is the time measured for the plasma concentration to decrease by one half. |
| Apparent Volume of Distribution (Vz/F) for all analytes. | up to 96 hours | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
| Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin. | up to 96 hours | — |
Countries
United States
Outcome results
None listed