A Pharmacokinetic Study of the Agile TCDS AG200-15 Following Weekly Application to Three Anatomical Sites (Abdomen, Buttock and Upper Torso) in Healthy Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Steady-State Concentration (Css) (48-168) Profile for EE
研究概览
简要总结
This is a pharmacokinetics and safety study over 3 weekly applications.
详细描述
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women, ages 18-45 years
- •Body mass index 18 - 32, and weight ≥ 110 lbs.
- •Willing to use a non-hormonal method of contraception if of childbearing potential, Or have already undergone previous bilateral tubal ligation or hysterectomy
- •Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
- •Willing to give informed consent to participate in study
- •Hemoglobin within normal range.
排除标准
- •Known or suspected pregnancy
- •A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
- •Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic)
- •Diabetes Mellitus
- •History of headaches with focal neurological symptoms
- •Current or history of clinically significant depression in the last year
- •Acute or chronic hepatocellular disease with abnormal liver function
- •History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
- •Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
研究组 & 干预措施
Abdomen, Buttock, Upper Torso
Patch was placed on abdomen, buttock then the upper torso excluding breast.
Intervention: AG200-15 patch
干预措施: AG200-15 (Drug)
Abdomen, Upper Torso, Buttock
Patch was placed on abdomen, upper torso excluding breast then the buttock.
Intervention: AG200-15 patch
干预措施: AG200-15 (Drug)
Buttock, Abdomen, Upper Torso
Patch was placed on the buttock, abdomen, then the upper torso excluding breast.
Intervention: AG200-15 patch
干预措施: AG200-15 (Drug)
Buttock, Upper Torso, Abdomen,
Patch was placed on the buttock, upper torso excluding breast then the abdomen
Intervention: AG200-15 patch
干预措施: AG200-15 (Drug)
Upper Torso, Abdomen, Buttock
Patch was placed on the upper torso excluding breast, abdomen then buttock.
Intervention: AG200-15 patch
干预措施: AG200-15 (Drug)
Upper Torso, Buttock, Abdomen
Patch was place on the upper torso excluding breast, buttock, then abdomen.
Intervention: AG200-15 patch
干预措施: AG200-15 (Drug)
结局指标
主要结局
Steady-State Concentration (Css) (48-168) Profile for EE
时间窗: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
时间窗: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Steady-State Concentration (Css) (48-168) Profile for LNG
时间窗: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
时间窗: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
次要结局
未报告次要终点