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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy postmenopausal women, aged 40-
- •Intact Uterus
排除标准
- •The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.
研究组 & 干预措施
Non-Obese
BMI <30 kg/m^2
干预措施: CE/BZA (Drug)
Non-Obese
BMI <30 kg/m^2
干预措施: Itraconazole (Drug)
Obese
BMI >= 30 kg/m^2
干预措施: CE/BZA (Drug)
Obese
BMI >= 30 kg/m^2
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.
时间窗: 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.
时间窗: up to 96 hours
次要结局
- Apparent Volume of Distribution (Vz/F) for all analytes.(up to 96 hours)
- Terminal Phase Elimination Half-Life (t1/2) 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)
- Apparent Oral Clearance (CL/F) for all analytes.(up to 96 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes.(up to 96 hours)
- Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.(up to 96 hours)