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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Obese | Other | BMI <30 kg/m^2 |
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| Obese | Other | BMI >= 30 kg/m^2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE/BZA | Drug | CE 0.45mg/BZA 20mg tablets, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 96 hours |
| Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin. | up to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SeaView Research, Inc. (Screening Office) | Miami | Florida | 33125 | United States | ||
| SeaView Research, Inc. |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Itraconazole | Drug | Two 100 mg capsules, once daily for 7 days |
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| CE/BZA | Drug | CE 0.45mg/BZA 20mg tablets, single dose on Day 5 |
|
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| CE/BZA | Drug | CE 0.45mg/BZA 20mg tablets, single dose |
|
|
| Itraconazole | Drug | Two 100 mg capsules, once daily for 7 days |
|
|
| CE/BZA | Drug | CE 0.45mg/BZA 20mg tablets, single dose on Day 5 |
|
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| Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin. | 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. | up to 96 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes. | up to 96 hours |
| 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. | 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. | up to 96 hours |
| Miami |
| Florida |
| 33126 |
| United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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