NCT00395395已完成1 期
A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
研究概览
简要总结
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy postmenopausal women
排除标准
- •Previous treatment with other osteoporosis medication
- •Other protocol defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
次要结局
- Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
- PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
- PK profile of salmon calcitonin nasal spray
研究者
研究点 (1)
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