NCT00411125已完成1 期
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake 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
- 86
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile of the new variant compared to the current variant on Day 1
研究概览
简要总结
This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal 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 profile of the new variant compared to the current variant on Day 1
Effect on bone resorption biomarker on Day 1
次要结局
- Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
- Effect on bone resorption biomarker after drug intake at different timepoints
- Effect of dosing at different timepoints on the pharmacokinetic profile
研究者
研究点 (1)
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