The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax
研究概览
简要总结
The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Pre-menopausal female of child-bearing potential.
- •Body Mass Index (BMI) between 19 and 35 kg/m^2, inclusive.
排除标准
- •On implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study.
- •Evidence of diabetes mellitus.
- •Participation in a study involving administration of an investigational compound within the past 3 months.
研究组 & 干预措施
Sequence 1
Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone
干预措施: ethinyl estradiol and levonorgestrel; exenatide (Drug)
Sequence 2
Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide
干预措施: ethinyl estradiol and levonorgestrel; exenatide (Drug)
Sequence 3
Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide
干预措施: ethinyl estradiol and levonorgestrel; exenatide (Drug)
结局指标
主要结局
Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax
时间窗: Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48
To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.
次要结局
- Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax(Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48)
- Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.(Baseline through Day 84)