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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
CE 0.45mg/BZA 20mg tablets, single dose
Two 100 mg capsules, once daily for 7 days
CE 0.45mg/BZA 20mg tablets, single dose on Day 5
SeaView Research, Inc. (Screening Office)
Miami, Florida, United States
SeaView Research, Inc.
Miami, Florida, United States
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.
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).
Time frame: up to 96 hours
Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin.
Time frame: 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.
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).
Time frame: up to 96 hours
Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.
Time frame: up to 96 hours
Apparent Oral Clearance (CL/F) for all analytes.
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 frame: up to 96 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes.
Time frame: up to 96 hours
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CE 0.45mg/BZA 20mg tablets, single dose
Two 100 mg capsules, once daily for 7 days
CE 0.45mg/BZA 20mg tablets, single dose on Day 5
Apparent Volume of Distribution (Vz/F) for all analytes.
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.
Time frame: up to 96 hours
Terminal Phase Elimination Half-Life (t1/2) for all analytes.
Terminal Phase Elimination Half-Life is the time measured for the plasma concentration to decrease by one half.
Time frame: up to 96 hours